Duns Number:015272206
Device Description: MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved dow MicroGlide MIS bipolar forceps, 10 1/4", working length 6 1/4", bayonet shafts, curved down 45º, 0.4mm wide non-stick tips, with guide stop, insulated, flat handle
Catalog Number
25-790-D45
Brand Name
Ambler Surgical
Version/Model Number
25-790-D45
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
826d0876-68bd-48a6-9c25-9bf31f334883
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 |