Duns Number:006999858
Device Description: Barrier Supreme Surgical Drape, 1 -Ply T180 Base, 1 Ply 6 3/4" x 7" Barrier SupremeReinfor Barrier Supreme Surgical Drape, 1 -Ply T180 Base, 1 Ply 6 3/4" x 7" Barrier SupremeReinforcement Pad on Back of Drape, 3" Round Fenestration, Concealed Hem Around Reinforcement Pad, Topstitching Around Fenestration, QCM on Front Bottom Left Corner, Hemmed All Around Size 31x33
Catalog Number
96301764
Brand Name
Barrier Supreme Surgical Drape
Version/Model Number
96301764
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
6c968e75-5a6c-4fd9-99c3-e015402ff216
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 |