Duns Number:326515533
Device Description: NON-Stick bipolar forceps 215 mm bayonet45° angl. up. 1,2 x 8.0 mm norm. classicblue insul NON-Stick bipolar forceps 215 mm bayonet45° angl. up. 1,2 x 8.0 mm norm. classicblue insulated, 2-Pin Plug grey
Catalog Number
WER-8U
Brand Name
Guenter Bissinger Medizintechnik GmbH
Version/Model Number
WER-8U
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"
Yes
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
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
63e14d04-8749-4013-8f47-710fa270d240
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1012 |