Duns Number:071595540
Device Description: 2.9MM, 70 DEGREE ENVISION AUTOCLAVABLE EYECUP SCOPE
Catalog Number
T2970
Brand Name
CONMED
Version/Model Number
T2970
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
-
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
K962075,K962075,K962075
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
670f6ee1-a12e-4342-a1a1-acb3abbf3806
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
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 |