Kirwan - Reusable Bipolar Forceps 5.0mm Exposure, Cup - KIRWAN SURGICAL PRODUCTS LLC

Duns Number:046355210

Device Description: Reusable Bipolar Forceps 5.0mm Exposure, Cup Stamp ES05 (Special)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Kirwan

Version/Model Number

15-5304S

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"

Yes

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 Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

8a571da7-1830-4f19-8462-844f7f4d58f1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KIRWAN SURGICAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 60
2 A medical device with a moderate to high risk that requires special controls. 1505
U Unclassified 2