Duns Number:008162518
Device Description: Love Kerrison Punch 8" fwd 5mm x 15mm TFP
Catalog Number
gS 71.7815
Brand Name
gSource
Version/Model Number
gS 71.7815
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTX
Product Code Name
Rongeur
Public Device Record Key
15a1a251-0d24-4c1c-b955-9de507c1c240
Public Version Date
August 10, 2022
Public Version Number
3
DI Record Publish Date
February 24, 2020
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 | 4617 |
2 | A medical device with a moderate to high risk that requires special controls. | 280 |