Model: 02820040
DI: 04048844150228
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
impactor for cup insert
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:
abb28c95-6f68-44c5-a8a4-ff40e69d0baa
Distribution Status:
In Commercial Distribution
DUNS Number:
324369826
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
04048844150228
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 32856
Name: Orthopaedic implant impactor, reusable
Definition:
A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.
FDA Product Codes
OQG
Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
OQI
Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Device Sizes
Device Size - Size Text:
40mm
Device Size - Size Type:
Device Size Text, specify