Forcep - Colibri Bipolar Electro Forceps, Insulated 1.8mm - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Colibri Bipolar Electro Forceps, Insulated 1.8mm Tip 30cm 11-3/4

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More Product Details

Catalog Number

7042-42I

Brand Name

Forcep

Version/Model Number

7042-42I

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

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

ab78d741-67d1-49ef-a3a4-05ec895d4d5a

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOROS U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2597
2 A medical device with a moderate to high risk that requires special controls. 416