Duns Number:006999858
Device Description: StanGuard Barrier Supreme Universal Fenestrated Drape 20X20 - RM (98 7833) USE: 22626022 StanGuard Barrier Supreme Universal Fenestrated Drape 20X20 - RM (98 7833) USE: 22626022 SMALL UNIV DRAPE KAUM
Catalog Number
22609122
Brand Name
Stanguard Drape
Version/Model Number
22609122
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
e5aaa5c3-d6c6-484a-bf21-fd93e0036030
Public Version Date
May 02, 2018
Public Version Number
3
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 |