Duns Number:071595540
Device Description: 4.0mm, 30° UHD Quicklatch C-Mount Arthroscope, 157 mm WL
Catalog Number
UHD4300CM
Brand Name
NA
Version/Model Number
UHD4300CM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 21, 2021
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)
Yes
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
4b8fc574-2139-4383-81ac-249659544e35
Public Version Date
August 23, 2021
Public Version Number
2
DI Record Publish Date
July 17, 2019
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 | 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 |