Duns Number:800149346
Device Description: 10 Sterile Non-Adherent Pads 2x3 inch 10/box
Catalog Number
0104034
Brand Name
Redicare
Version/Model Number
Non Adherent Pad 2" x 3"
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
a6b3a783-b1ba-4d59-8073-1abb9e80fab2
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
July 28, 2020
Package DI Number
B70901040342
Quantity per Package
48
Contains DI Package
B70901040341
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |