Duns Number:071595540
Device Description: Adjustable Retractor Cannula 6.0mm x 85mm with outflow
Catalog Number
C06-85
Brand Name
ARC
Version/Model Number
C06-85
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
NBH
Product Code Name
Accessories, arthroscopic
Public Device Record Key
8cd5d036-3462-49ad-8e6c-7f8848190c0d
Public Version Date
October 20, 2021
Public Version Number
1
DI Record Publish Date
October 12, 2021
Package DI Number
10653405001621
Quantity per Package
1
Contains DI Package
20653405001628
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |