Duns Number:532283264
Catalog Number
AACL30502120
Brand Name
Tip ClearLift QS 5x5 with Depth Control Set (Female)
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072564
Product Code
FTC
Product Code Name
Light, Ultraviolet, Dermatological
Public Device Record Key
0972f458-1064-4b14-9f7e-2614d7b8686d
Public Version Date
January 07, 2022
Public Version Number
1
DI Record Publish Date
December 30, 2021
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 | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 167 |