Device
Cloward Retractor, 13mm
Manufacturer
OMNIA MEDICAL, LLC
Model: 99-5A-CL13 DI: 00843511128500 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
Cloward Retractor, 13mm
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: 1089b80b-a5c8-43db-b2a8-c8da8a237e80
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: 00843511128500
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46774
Name: Surgical retractor/retraction system blade, reusable
Definition:
A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument