Duns Number:327681359
Device Description: Bipolar forceps, Non-Stick, Bayonet Straight, 230 mm length, Tip 2,0 mm X 8 mm, with irrig Bipolar forceps, Non-Stick, Bayonet Straight, 230 mm length, Tip 2,0 mm X 8 mm, with irrigation, US-Pin
Catalog Number
69.344.21
Brand Name
LAZIC
Version/Model Number
69.344.21
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
c485cde4-1500-4ad2-91ba-603b8286548b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 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 | 1084 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1125 |