GEM BiPolar Jewelers Forceps - Reusable bipolar forceps designed to function as - SYNOVIS MICRO COMPANIES ALLIANCE, INC

Duns Number:031284586

Device Description: Reusable bipolar forceps designed to function as active electrodes or as accessories to ac Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes.

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More Product Details

Catalog Number

521440251010

Brand Name

GEM BiPolar Jewelers Forceps

Version/Model Number

GEM4025J-NS-C

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

K130669

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

2d0c53d8-740f-4d09-a753-7a6481b05117

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNOVIS MICRO COMPANIES ALLIANCE, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 55