Catalog Number

6358

Brand Name

KOHDENT

Version/Model Number

6358

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EGN

Product Code Name

SCISSORS, SURGICAL TISSUE, DENTAL

Public Device Record Key

351ec9d4-e564-4bdb-860b-765cfbfdf516

Public Version Date

September 30, 2021

Public Version Number

1

DI Record Publish Date

September 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-