Duns Number:081840873
Device Description: DJA PLANTAR FASCIITIS NIGHT SPLINT, BLACK, LARGE/XLARGE
Catalog Number
-
Brand Name
DONJOY ADVANTAGE
Version/Model Number
DA161FB01-BLK-L,XL
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)
-
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
e6526e0e-7b4e-4bab-adca-7385779828ce
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 19, 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 | 784 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
| 3 | A medical device with high risk that requires premarket approval | 8 |