Duns Number:006999858
Device Description: Barrier Supreme Eye Drape, 22x22, 1 Ply Softweave, 1 Ply Barrier Supreme 7x7 Reinforcement Barrier Supreme Eye Drape, 22x22, 1 Ply Softweave, 1 Ply Barrier Supreme 7x7 Reinforcement Pad, 3" Round Fenestration, Concealed Hems Around Fenestration and Reinforcement Pad, Hemmed All Around, QCM on Front Bottom Right Corner
Catalog Number
96801654
Brand Name
Barrier Supreme Eye Drape
Version/Model Number
96801654
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
22f287fb-995c-4f02-91ff-dc0c2eb2e7b0
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 |