Duns Number:006999858
Device Description: WRAPPER STANDARD SUPREME KAUM 23X23 JADE 2PLY - RM (98 8281) USE: 21532002
Catalog Number
215U6402
Brand Name
Standard Supreme Wrapper
Version/Model Number
215U6402
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
K172207,K172207
Product Code
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
1391c78e-bde6-4016-be4a-a00d352c9da4
Public Version Date
November 08, 2019
Public Version Number
4
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 |