Duns Number:006999858
Device Description: LEG WRAP Standard Supreme Surgical Drape T180 MISTY 6X112.75 - 2PLY HEMMED ALL SIDES SR15 LEG WRAP Standard Supreme Surgical Drape T180 MISTY 6X112.75 - 2PLY HEMMED ALL SIDES SR15563
Catalog Number
96500872
Brand Name
Standard Supreme Surgical Drape
Version/Model Number
96500872
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
5d5c137b-0be9-41fc-bb9a-003f74372290
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 29, 2018
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 |