Model: SUP3121GRY
DI: 00810178885954
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Shoulder Compression Ice Wrap
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
183b078d-2cb3-43f2-b870-1b8949a04318
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:
00810178885954
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37240
Name: Musculoskeletal hot/cold therapy pack, reusable
Definition:
A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.
FDA Product Codes
IME
Pack, Hot Or Cold, Reusable