Duns Number:607846297
Device Description: CODMAN Bayonet Bipolar Forceps Irrigating Non Stick Mirror Finish 8 3/4 Inches (22.2cm) 0. CODMAN Bayonet Bipolar Forceps Irrigating Non Stick Mirror Finish 8 3/4 Inches (22.2cm) 0.5mm Angle Down Tip
Catalog Number
802930
Brand Name
CODMAN
Version/Model Number
80-2930
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K963499
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
b2c2fb94-2389-4fd8-8308-94d4526d1296
Public Version Date
September 01, 2022
Public Version Number
5
DI Record Publish Date
April 12, 2017
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |