Duns Number:315018218
Device Description: KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), regular, KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), regular, width: 5 mm, opening width: 12 mm, detachable, with ejector, standard, non-sterile, reusable, to be used with: JF120R
Catalog Number
FK916B
Brand Name
NOIR
Version/Model Number
FK916B
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRY
Product Code Name
PUNCH, SURGICAL
Public Device Record Key
eba5b0a4-d600-4a22-99fc-a9b8e2362e17
Public Version Date
October 19, 2021
Public Version Number
3
DI Record Publish Date
June 19, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |