Duns Number:690275362
Device Description: A1-12 (FDA/1EA)
Catalog Number
-
Brand Name
POTENZA Tip
Version/Model Number
A1-12
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201685,K201685
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
995b6f56-35f4-4076-96ba-4c6ecc1bb456
Public Version Date
April 06, 2022
Public Version Number
1
DI Record Publish Date
March 29, 2022
Package DI Number
18800020101133
Quantity per Package
5
Contains DI Package
08800020101136
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |