Duns Number:187502109
Device Description: XL Aggressive Plus, Hip Cutter. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, XL Aggressive Plus, Hip Cutter. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375-704-500, 0375-708-500. Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight
Catalog Number
0385-544-000
Brand Name
Formula
Version/Model Number
0385544000
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
-
Product Code
GFA
Product Code Name
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Public Device Record Key
ff9a0282-8f1d-4aa9-bc66-4c43a87e773c
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 22, 2018
Package DI Number
37613327055109
Quantity per Package
5
Contains DI Package
07613327055108
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |