CODMAN - CODMAN YASARGIL Bipolar Forceps Bayonet Non Stick - CODMAN & SHURTLEFF, INC.

Duns Number:607846297

Device Description: CODMAN YASARGIL Bipolar Forceps Bayonet Non Stick Mirror Finish Tip Width 0.7mm 171mm

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More Product Details

Catalog Number

802973

Brand Name

CODMAN

Version/Model Number

80-2973

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

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

K963499

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

1817ce5c-31fa-4fb1-bae7-0c2416a27202

Public Version Date

September 01, 2022

Public Version Number

5

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CODMAN & SHURTLEFF, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 1054
3 A medical device with high risk that requires premarket approval 11