Duns Number:069936106
Device Description: 25 TOWELS, DISP, BLUE (FF) N/S
Catalog Number
0028
Brand Name
NOVO Health Services, LLC
Version/Model Number
0028
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 02, 2020
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)
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
c9e246b6-aac6-4f81-bada-23f0a1839593
Public Version Date
June 03, 2020
Public Version Number
4
DI Record Publish Date
October 09, 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 | 226 |
2 | A medical device with a moderate to high risk that requires special controls. | 859 |