Duns Number:065762392
Device Description: Cotton Cast Padding, 4" x 4.1yds, 12 Rolls/Bag,
Catalog Number
PO2003
Brand Name
Biotronix Healthcare Cotton Cast Padding
Version/Model Number
PO2003
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
ITG
Product Code Name
Bandage, Cast
Public Device Record Key
ee32cf57-2325-49b0-84fb-aeb0c8f454ca
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
October 26, 2019
Package DI Number
10858835007896
Quantity per Package
6
Contains DI Package
00858835007899
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |