Duns Number:081840873
Device Description: DJP BIONIC ANKLE, SLIME GREEN, SMALL, RIGHT
Catalog Number
-
Brand Name
DONJOY PERFORMANCE
Version/Model Number
DP151AB01-SGR-S-R
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"
Yes
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
ITW
Product Code Name
JOINT, ANKLE, EXTERNAL BRACE
Public Device Record Key
68b39441-8ad1-432e-b468-6110d0dc6cb2
Public Version Date
August 31, 2022
Public Version Number
1
DI Record Publish Date
August 23, 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 |