Duns Number:328485453
Device Description: QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 3m QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 3mm, 8"
Catalog Number
VK.J803CT
Brand Name
Quick Release
Version/Model Number
VK.J803CT
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
748c5d66-86d0-4625-930c-74c3ea97c425
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 28, 2016
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 |