Model: 500.000
DI: 00840277411105
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Orthopedic Kit
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1e220fd2-140d-474f-adc0-1e28e49e48bd
Distribution Status:
In Commercial Distribution
DUNS Number:
964053560
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840277411105
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44052
Name: Orthopaedic surgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
FDA Product Codes
OJH
Orthopedic Tray