Duns Number:187502109
Device Description: [Auger Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Dama [Auger Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight]
Catalog Number
0375-450-500
Brand Name
Formula
Version/Model Number
0375450500
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
a04c8288-d1fa-48ac-8e1c-d2cd39b99df2
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
September 12, 2018
Package DI Number
37613327061728
Quantity per Package
5
Contains DI Package
07613327061727
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 |