Duns Number:096372255
Device Description: Towel Safety, White Pretreated, 400/cs
Catalog Number
68-402NS-PT
Brand Name
DeRoyal
Version/Model Number
68-402NS-PT
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"
Yes
For Single-Use
-
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
FRL
Product Code Name
FIBER, MEDICAL, ABSORBENT
Public Device Record Key
de7d154f-9216-4dc0-afb4-06281e7260c6
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 2021
Package DI Number
50749756767076
Quantity per Package
400
Contains DI Package
00749756767071
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |