Model: 08-8980J
Catalog: 08-8980J
DI: 10198956381131
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
SUTURE TRAY
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
77b7065d-cfd5-4a19-87ff-97926f2f5d89
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:
50198956381139
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956381131
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956381131
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 56303
Name: Suture kit, non-medicated
Definition:
A collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.
FDA Product Codes
OVN
Suture kit
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