Duns Number:006999858
Device Description: Barrier Supreme Wound Drape 1-Ply Barrier Supreme, with 1 1/2"x3 1/2" Oval Fenestration, Q Barrier Supreme Wound Drape 1-Ply Barrier Supreme, with 1 1/2"x3 1/2" Oval Fenestration, QCM on Front Bottom Right Corner, 21x31
Catalog Number
95687392
Brand Name
Barrier Supreme Wound Drape
Version/Model Number
95687392
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
-
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
011831d5-39d5-447f-9522-fea236f03907
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
April 03, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |