Ambler Surgical - Yasargil MIS bipolar forceps, 11 3/4", working - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Yasargil MIS bipolar forceps, 11 3/4", working length 8", bayonet shafts, 1.5mm wide non-s Yasargil MIS bipolar forceps, 11 3/4", working length 8", bayonet shafts, 1.5mm wide non-stick tips, insulated, fenestrated flat handle

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More Product Details

Catalog Number

26-668

Brand Name

Ambler Surgical

Version/Model Number

26-668

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

f08c64ac-5e24-4717-8c2d-19fd1eabb18c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMBLER SURGICAL CORP." Characteristics
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