Device
OXFKLSYN
Manufacturer
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model: OXFKLSYN Catalog: OXFKLSYN DI: 00889024686182 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 247cbf3d-cc09-4616-9946-bc4cc2c78518
Distribution Status: In Commercial Distribution
DUNS Number: 137354267
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: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00889024686182
Type: Primary
Issuing Agency: GS1
GMDN
Code: 45493
Name: Surgical saw blade, reciprocating, single-use
Definition:
A sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.
FDA Product Codes
GFA
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL