Duns Number:315304071
Device Description: END CUTTER Ø 3.5MM color code red, PACK=1 PC, WL 126.5mm, for use with the motor handpiec END CUTTER Ø 3.5MM color code red, PACK=1 PC, WL 126.5mm, for use with the motor handpiece M4, in Arthroscopy, reusable
Catalog Number
8567.561
Brand Name
NA
Version/Model Number
8567561
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
084fe741-0893-4d4e-9ca4-d580d2291782
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
September 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 |
|---|---|---|
| 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 |