Model: 28-7677E
Catalog: 28-7677E
DI: 10198956388512
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
ARTHROGRAM TRAY
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1e3f2e93-22ae-4998-8f0d-5a6ffe841f79
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:
50198956388510
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956388512
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956388512
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 15316
Name: Arthrogram kit
Definition:
A collection of instruments, pharmaceuticals, equipment and various supplies intended to be used to visualize a joint by radiographic study after injection of a contrast medium into the joint space. This is a reusable device after the appropriate cleaning/sterilization of the instruments/reusable products and the consumable/pharmaceutical products have been replenished.
FDA Product Codes
OII
Arthrogram tray