Duns Number:948025002
Device Description: Reusable Bipolar Forceps 10 1/2" (26.6cm) Cushing Bayonet, Angled Insulated, 1mm Tip
Catalog Number
-
Brand Name
Life Instruments
Version/Model Number
780-1011-3
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
K811820
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f9d87aa5-01e2-494d-b482-e305394be9b8
Public Version Date
August 05, 2020
Public Version Number
5
DI Record Publish Date
July 04, 2016
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 | 5454 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |