Duns Number:658318113
Device Description: Copioumed's surgical drape can effectively block the penetration of bodily fluids during s Copioumed's surgical drape can effectively block the penetration of bodily fluids during surgery, prevent cross-infection, and maintain a sterile field at the surgical site.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
SDS0B101-1
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"
-
For Single-Use
Yes
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
ced2d5ea-4da1-4d4f-bf18-5729431f4e92
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
Package DI Number
14719882250894
Quantity per Package
60
Contains DI Package
04719882250897
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 | 2 |