Duns Number:878070325
Device Description: Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Flat SAM Kay Kare Brace Kit; Each Kit Includes Disposable Multi Purpose Wrap, and 35x4.25 Flat SAM Splint.
Catalog Number
10-30105 DS
Brand Name
Kay Kare
Version/Model Number
10-30105 DS
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
Yes
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
NOC
Product Code Name
Splint, Extremity, Non-Inflatable, External, Non-Sterile
Public Device Record Key
77c85bf0-1fe2-4581-9ec9-ce4cbe0d9231
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
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 | 72 |