Model: AR-9953-05
Catalog: AR-9953-05
DI: 00888867504677
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Reduction Nut , Proximal Humeral Plate
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e1dffe3e-abdf-4339-846b-d2ef1a2534fb
Distribution Status:
In Commercial Distribution
DUNS Number:
131747628
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00888867504677
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 48025
Name: Orthopaedic bone-fragment manipulator, reusable
Definition:
A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a reusable device.
FDA Product Codes
MDM
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE