Duns Number:328485453
Device Description: Kerrison Rongeur with ring handle, thin footplate, 12 mm bite opening, 40d UP, 2 Kerrison Rongeur with ring handle, thin footplate, 12 mm bite opening, 40d UP, 2 mm, 8", black coated
Catalog Number
VK.802RHE
Brand Name
Quick Release
Version/Model Number
VK.802RHE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
HAE
Product Code Name
RONGEUR, MANUAL
Public Device Record Key
f22b6380-26ef-484b-9348-58a3d9ef2905
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 19, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 228 |