Duns Number:929236305
Device Description: Top Dent Disposable Micro-Applicators, M8 Regular 2.0mm, Green
Catalog Number
681751
Brand Name
Lifco
Version/Model Number
681751
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
KXR
Product Code Name
APPLICATOR, RESIN
Public Device Record Key
55e124a6-dc06-46f4-8cd6-e8e51d23ba8c
Public Version Date
October 05, 2022
Public Version Number
3
DI Record Publish Date
August 13, 2022
Package DI Number
20789594001412
Quantity per Package
200
Contains DI Package
00789594001418
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 | 43 |