Device
TREND UNIVERSAL WRIST & THUMB RIGHT
Manufacturer
Orthofix US LLC
Model: DCT-200-R Catalog: DCT-200-R DI: 00850071315448 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-25 Current Version: 2026-05-04
Description
TREND UNIVERSAL WRIST & THUMB RIGHT
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: caf0b49e-bfd4-44e3-8907-3fd4c80570a3
Distribution Status: In Commercial Distribution
DUNS Number: 927083808
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: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00850071315448
Type: Primary
Issuing Agency: GS1
GMDN
Code: 41459
Name: Wrist/hand orthosis
Definition:
An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.
FDA Product Codes
IQI
ORTHOSIS, LIMB BRACE