Model: SUP3126GRYM
DI: 00810178887149
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Abdominal Ostomy Belt (Medium)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c5d1b3d1-ed60-4504-90ed-6997554bd1c1
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:
00810178887149
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62951
Name: Ostomy appliance belt
Definition:
An adjustable and/or elastic, strip-like device intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the device which is worn by the patient; the device does not include an attachment flange, plate, or ring and is not intended to protect the ostomy site or appliance (i.e., does not include a shield). It is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a reusable device.
FDA Product Codes
EXE
Protector, Ostomy