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TRUTACK Hernia Fixation Device TRUTACK Hernia FixationTRUTACK Hernia Fixation DeviceM30)

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The TRUTACK Hernia Fixation Device is a precision-engineered surgical tool specifically designed for the secure fixation of mesh during hernia repair procedures. This device utilizes non-absorbable, single-point fixation with titanium tacks, ensuring durable and reliable mesh placement. Its manual firing mechanism provides surgeons with controlled deployment of 30 fasteners, each ranging between 3 to 5 mm in length, optimizing precision and minimizing tissue trauma. The device features an intuitive indicator system to monitor tack usage and remaining fasteners, enhancing operative efficiency. With a fixation cannula length of 31 to 35 cm, it is designed for ergonomic handling in laparoscopic surgeries. TRUTACK conforms to stringent regulatory standards, including the Medical Device Rules (MDR) 2017 and ISO 13485 certification, and is MRI compatible, facilitating postoperative imaging without removal. Each batch undergoes rigorous quality testing, ensuring compliance and reliability. With a 3-year shelf life and a prescription requirement, the TRUTACK Hernia Fixation Device is an essential asset for healthcare providers focused on high-quality hernia repair solutions.

Key Features

Features Description
Fixation Material Non Absorbable
Type of Fixation Single Point
Material of Tack/Glue Titanium
Mode of Firing Manual
Number of Fasteners/Hooks 30
Length of Fasteners/Hooks 3 mm to 5 mm
Fixation Cannula Length 31 to 35 cm
MRI Compatibility Yes
Usage Indicator Yes, indicates fastener usage and remaining count
Shelf Life 3 years from manufacture date
Attributes Description
Compliance Medical Device Rules (MDR) 2017 as amended till date
Valid Medical Device License Number MFG/MD/2021/000143
Manufacturing Unit Certification ISO 13485 (Latest)
Test Report Availability Yes, for each batch as per MDR 2017
Prescription Required Yes
Absorption Duration Not applicable (Non-absorbable)
Minimum Shelf Life at Delivery 3/4th of Total Shelf Life

*Disclaimer: The above description has been AI-generated and has not been audited or verified for accuracy. It is recommended to verify product details independently before making any purchasing decisions.

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Yes, the TRUTACK Hernia Fixation Device is MRI compatible, allowing postoperative imaging without the need to remove the device.

No, the TRUTACK device uses non-absorbable titanium tacks exclusively for durable mesh fixation.

It features an integrated indicator that displays the usage status and the number of remaining fasteners/hooks to the surgeon.

The device provides single-point fixation ensuring precise and secure mesh placement during hernia repair.

The fasteners/hooks used are between 3 mm to 5 mm in length, suitable for effective mesh fixation.

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Country Of Origin: India

Product Description Hernia Fixation Device
Purpose For fixation of mesh during hernia procedure
PRODUCT INFORMATION
Fixation material Non Absorbable material
Type of fixation Single Point
Material of Tack/Glue Titanium
Mode of Firing for device Manual
Duration of Absorbtion NA in case of Non Absorbable
MRI Compatibility Yes
Number of Fasteners/Hooks 30
Length of Fasteners/Hooks (±0.5 mm) 3 mm to 5 mm
The fixation device shall have indicator regarding usage of fasteners/hooks and remaining tackers Yes
Length of the fixation canulla of device in Centimeter (±0.5 mm) 31 to 35
CERTIFICATIONS
Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
Availability of valid Medical Device license for the product issued from the competent  
Valid Medical Device License Number MFG/MD/2021/000143
Certification for manufacturing unit ISO:13485 (Latest)
Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes

SHELF LIFE
Shelf life from the date of manufacture (Years) 3 year


Prescription Required

Product Description Hernia Fixation Device
Purpose For fixation of mesh during hernia procedure
PRODUCT INFORMATION
Fixation material Non Absorbable material
Type of fixation Single Point
Material of Tack/Glue Titanium
Mode of Firing for device Manual
Duration of Absorbtion NA in case of Non Absorbable
MRI Compatibility Yes
Number of Fasteners/Hooks 30
Length of Fasteners/Hooks (±0.5 mm) 3 mm to 5 mm
The fixation device shall have indicator regarding usage of fasteners/hooks and remaining tackers Yes
Length of the fixation canulla of device in Centimeter (±0.5 mm) 31 to 35
CERTIFICATIONS
Compliance to Medical Device Rules (MDR) 2017 as amended till date Yes
Availability of valid Medical Device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
Valid Medical Device License Number MFG/MD/2021/000143
Certification for manufacturing unit ISO:13485 (Latest)
Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date Yes
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
SHELF LIFE
Shelf life from the date of manufacture (Years) 3 year
Minimum shelf life of the product at the time of delivery to the consignee 3/4 th of Total Shelf Life




Medical Devices And Supplies

TRUTACK Hernia Fixation Device

Hernia Mesh Fixation Tool

Titanium Tack Hernia Device

Manual Hernia Fixation Device

Laparoscopic Fixation Device

Non-absorbable Hernia Fixator

Surgical Hernia Tack Device

TRUTACK Hernia Fixation Device TRUTACK Hernia FixationTRUTACK Hernia Fixation DeviceM30)

Inclusive of all taxes

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radhakrushna medicals

Yavatmal , India

Distributor, Exporter, Wholesaler

GST- 27aempt2491q2zf

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