Duns Number:080361159
Device Description: Rolyan Sof-Stretch Extension Splint, White, X-Large, Individual
Catalog Number
-
Brand Name
PERFORMANCE HEALTH
Version/Model Number
A99764
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
82ec3310-0c77-4abd-a6cd-364a5f28e60b
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |