Model: SUP3117BLKL
DI: 00810178884971
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Shoulder Brace Cross Support (Large)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e83f2cf0-b7bf-4fd3-bc18-ea0dcfaa19b6
Distribution Status:
In Commercial Distribution
DUNS Number:
047025993
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
00810178884971
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67640
Name: Shoulder strap orthosis
Definition:
A prefabricated (non-customized) non-rigid wearable device designed to support and facilitate movement of the shoulder joint to support the healing of an injury. It is typically in the form of a sleeve designed to be worn around the upper arm/shoulder and secured with an adjustable strap around the chest. It is not a sling and does not include a hinging mechanism. This is a reusable device.
FDA Product Codes
IQI
Orthosis, Limb Brace