Duns Number:109903521
Device Description: ANKLE STABILIZATION KITS, DISPOSABLE 6 UNITS
Catalog Number
72202931
Brand Name
NA
Version/Model Number
72202931
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZW
Product Code Name
EXPANDER, SURGICAL, SKIN GRAFT
Public Device Record Key
5781ad49-20a7-4250-88ec-46910b02e4cc
Public Version Date
November 06, 2020
Public Version Number
5
DI Record Publish Date
August 24, 2016
Package DI Number
20885554018282
Quantity per Package
6
Contains DI Package
00885554018288
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |