Model: PO69LEKOC
Catalog: PO69LEKOC
DI: 10198956439412
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
KIT, LOWER EXTREMITY
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
de786a29-2bbf-419d-a5e3-3860073b6631
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50198956439410
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956439412
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956439412
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature