Duns Number:020198912
Device Description: Full Radius BoneCutter Blade
Catalog Number
7206011
Brand Name
N/A
Version/Model Number
N/A
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
Yes
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
K012652,K012652
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
4e7b77a0-78e0-43e8-92cb-86272e028e4e
Public Version Date
July 04, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
30885825013616
Quantity per Package
6
Contains DI Package
00885825013615
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 304 |
2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
U | Unclassified | 12 |