Duns Number:792528510
Device Description: Kerrison, Ceramic Coat,Curved Up w/o Hinge, 40 Degree Up, TW 2 mm, WL 200 mm (8")
Catalog Number
-
Brand Name
Millennium
Version/Model Number
85-64103056
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
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
4daa212a-6ab6-45ae-a87e-6c84b7d6b166
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 08, 2021
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 | 6832 |
2 | A medical device with a moderate to high risk that requires special controls. | 9482 |