Duns Number:783518983
Device Description: • Fully adjustable VELCRO allows for universal fit• Ideal treatment for: - Carpal tunnel • Fully adjustable VELCRO allows for universal fit• Ideal treatment for: - Carpal tunnel syndrome- Arthritis- Mild strains or sprains• Provides support to weak or injured wrists• Improves wrist joint function• Available for Right or Left wrist
Catalog Number
1591
Brand Name
True Support Orthopedic Wrist Brace
Version/Model Number
50001-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILH
Product Code Name
Splint, Hand, And Components
Public Device Record Key
786bf09f-67f6-499b-999d-7f9a4fed84f1
Public Version Date
October 03, 2022
Public Version Number
4
DI Record Publish Date
August 07, 2018
Package DI Number
10891237001598
Quantity per Package
150
Contains DI Package
00891237001591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |