Duns Number:015272206
Device Description: Yasargil MIS bipolar forceps, 11 3/4", working length 8", bayonet shafts, 0.4mm wide non-s Yasargil MIS bipolar forceps, 11 3/4", working length 8", bayonet shafts, 0.4mm wide non-stick tips, insulated, fenestrated flat handle
Catalog Number
26-660
Brand Name
Ambler Surgical
Version/Model Number
26-660
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
K123478
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
4f383b30-aecb-48fe-88d8-cdccad22bbd4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |