KORONA - KORONA Tri Staple - (L)12.5mm, 10mmx8mm - HNM TOTAL RECON LLC

Duns Number:080024940

Device Description: KORONA Tri Staple - (L)12.5mm, 10mmx8mm

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


More Product Details

Catalog Number

HTR-01-820563

Brand Name

KORONA

Version/Model Number

HTR-01-820563

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072298

Product Code Details

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Device Record Status

Public Device Record Key

163dce66-13c7-428d-bd2c-3856937a7064

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HNM TOTAL RECON LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 913