Duns Number:109903521
Device Description: MEDIUM/LARGE WRIST STABILIZATION KITS, DISPOSABLE 5 PER MEDIUM/LARGE WRIST STABILIZATION KITS, DISPOSABLE 5 PER CASE
Catalog Number
72201551
Brand Name
NA
Version/Model Number
72201551
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
FWZ
Product Code Name
Accessories, operating-room, table (kit)
Public Device Record Key
eca02f6b-be0c-48a3-988b-e5ed087a486b
Public Version Date
October 09, 2020
Public Version Number
5
DI Record Publish Date
August 29, 2015
Package DI Number
23596010604976
Quantity per Package
5
Contains DI Package
03596010604972
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 |