Duns Number:092312735
Device Description: BULK PIN LICE COMB MINI (LONG PIN)
Catalog Number
-
Brand Name
Ezy Dose
Version/Model Number
700395/HK700395
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
Yes
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
171b5aa1-1c3e-4085-a265-c5e108154725
Public Version Date
November 05, 2020
Public Version Number
1
DI Record Publish Date
October 28, 2020
Package DI Number
20079573000766
Quantity per Package
60
Contains DI Package
00079573000762
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |