Device
Reduction Scew Tab Breaker
Manufacturer
Xtant Medical Holdings, Inc.
Model: 02-RS-TAB-BREAKER Catalog: 02-RS-TAB-BREAKER DI: 00840311251360 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Reduction Scew Tab Breaker
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: fdf21529-f0c8-45fa-98c1-ff293d93e44c
Distribution Status: In Commercial Distribution
DUNS Number: 081224143
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
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
Item #1 - Device ID: 00846468057398
Item #1 - Device ID Type: Previous
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00840311251360
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 44539
Name: Surgical flat-nosed pliers
Definition:
A heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.
FDA Product Codes
HTC
PLIERS, SURGICAL