Model: CW41L54
DI: 00636257213346
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-24
Current Version: 2026-05-04
Description
!DO CF PREMIUM WRIST BRACE LEFT LG
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bc420c96-9642-4586-824e-3f12b7cd5d60
Distribution Status:
In Commercial Distribution
DUNS Number:
960754430
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00636257213346
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41458
Name: Wrist orthosis
Definition:
A prefabricated (non-customized), non-rigid, externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.
FDA Product Codes
IQI
ORTHOSIS, LIMB BRACE