Duns Number:082594540
Device Description: KERRISON Bone Punch conventional, 90 °, downwards cutting, 8", (205 mm), width: 5 mm, with KERRISON Bone Punch conventional, 90 °, downwards cutting, 8", (205 mm), width: 5 mm, without ejector, thin, non-sterile, reusable
Catalog Number
FF815R
Brand Name
AESCULAP
Version/Model Number
FF815R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 25, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HAE
Product Code Name
RONGEUR, MANUAL
Public Device Record Key
6f06eec9-1b9d-4d1a-abeb-1b4ccdb3139f
Public Version Date
March 01, 2022
Public Version Number
4
DI Record Publish Date
April 30, 2019
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 | 3239 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 683 |