Duns Number:060272465
Device Description: Nix Premium Metal Comb
Catalog Number
-
Brand Name
Nix
Version/Model Number
024793
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
LJL
Product Code Name
Detectors And Removers, Lice, (Including Combs)
Public Device Record Key
f53e0698-8549-46ff-b605-0ae82c8d9cbd
Public Version Date
July 01, 2020
Public Version Number
1
DI Record Publish Date
June 23, 2020
Package DI Number
10363736247932
Quantity per Package
1
Contains DI Package
00363736247935
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Single
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |
U | Unclassified | 14 |