Device
Bent Straight awl
Manufacturer
OMNIA MEDICAL, LLC
Model: 17-5A-AWL1-B DI: 00843511128463 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
Bent Straight awl
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: 53128808-aa05-4827-a63d-75b5480483f2
Distribution Status: In Commercial Distribution
DUNS Number: 079467378
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
Device ID: 00843511128463
Type: Primary
Issuing Agency: GS1
GMDN
Code: 15275
Name: Bone awl, reusable
Definition:
A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument