Duns Number:315304071
Device Description: BURR ROUND Ø 4.5MM color code gray, PACK=1 PC, WL 126.5mm, with lateral protection, for u BURR ROUND Ø 4.5MM color code gray, PACK=1 PC, WL 126.5mm, with lateral protection, for use with the motor handpiece M4, for extraction of bony structures, in Arthroscopy, reusable
Catalog Number
8568.301
Brand Name
NA
Version/Model Number
8568301
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
4449753e-bdd2-4786-a6c5-50ca3f188880
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |