Ejector Punch Plus Rongeur - Ejector Punch Plus Rongeur 5mm x 40 Degree 7" - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Ejector Punch Plus Rongeur 5mm x 40 Degree 7"

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


More Product Details

Catalog Number

7381-45

Brand Name

Ejector Punch Plus Rongeur

Version/Model Number

7381-45

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

HTX

Product Code Name

Rongeur

Device Record Status

Public Device Record Key

139c9c66-0f7c-45c6-a4b2-109be0d57af0

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

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