Model: SUP3116R
DI: 00810178884759
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
Hip ROM Brace (Right)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0781efba-e729-4b34-8ec9-943e23842be5
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:
Yes
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:
00810178884759
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36228
Name: Hip orthosis
Definition:
A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or improve function of the hip; it is not dedicated to infants. It is typically adjustable and comprised of components that include a hip/pelvic girdle, thigh cuff, and articulated hip portion. This is a reusable device.
FDA Product Codes
ITS
Joint, Hip, External Brace