Duns Number:332893028
Device Description: X-Fine bipolar forceps, NON-STICK, bayonet, tip straight, tip 0,4x4,0 mm, length 20 cm
Catalog Number
80-150-20
Brand Name
Bipolar Forceps
Version/Model Number
80-150-20
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
K101080
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
d324b355-8750-4a30-9e5e-a7a0b3533301
Public Version Date
April 10, 2019
Public Version Number
1
DI Record Publish Date
April 02, 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 | 1960 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |