Duns Number:016889401
Device Description: Hooded Abrasion Bur; sml joint (orange; orange or blue; blue)
Catalog Number
ST375-647-000
Brand Name
Sustainable Technologies
Version/Model Number
ST375-647-000
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
K172092,K172092,K172092
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
9bfb31db-e134-4418-83e7-996c76241dc1
Public Version Date
July 04, 2022
Public Version Number
6
DI Record Publish Date
December 13, 2019
Package DI Number
10810041635898
Quantity per Package
5
Contains DI Package
00810041635891
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3993 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1216 |