Duns Number:536935331
Device Description: The complete PANTA removal set includes instruments to be used for the removal of all PANT The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail system.
Catalog Number
REPANTASET
Brand Name
PANTA
Version/Model Number
REPANTASET
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091788
Product Code
HSB
Product Code Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Public Device Record Key
9a6cdd19-36aa-4bcb-ba50-9ecc49919c9a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |