Device
INFINEX VATS UltraGripX TC Needle Holder With Straight Jaws For Suture Size 4/0 and Smaller Shaft 7 mm Working Length 21.5 cm - 8 1/2" Overall Length 34 cm - 13 1/1" Stainless Stee...
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: XCV-995-03
DI: 05056111335499
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
INFINEX VATS UltraGripX TC Needle Holder With Straight Jaws For Suture Size 4/0 and Smaller Shaft 7 mm Working Length 21.5 cm - 8 1/2" Overall Length 34 cm - 13 1/1" Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8a672ca8-cf02-46b9-9b79-eb7b8e89ba71
Distribution Status:
In Commercial Distribution
DUNS Number:
216232502
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05056111335499
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12726
Name: Suturing needle holder, reusable
Definition:
A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.
FDA Product Codes
FHQ
HOLDER, NEEDLE, GASTROENTEROLOGIC