Duns Number:003152968
Device Description: The Sterile Drape is designed to function as a protective barrier between the sterile and The Sterile Drape is designed to function as a protective barrier between the sterile and non-sterile environments during surgical procedures
Catalog Number
SD100
Brand Name
Sterile Drape
Version/Model Number
SD100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKK
Product Code Name
Sudan Iv
Public Device Record Key
aba2f708-cf54-414d-8081-9393bb6e1daa
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
March 21, 2019
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |