Catalog Number

-

Brand Name

Tontarra Medizintechnik GmbH

Version/Model Number

630-471-16

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEN

Product Code Name

Forceps, General & Plastic Surgery

Public Device Record Key

bdc84806-52fc-4755-88a7-6cf646d14255

Public Version Date

March 26, 2020

Public Version Number

1

DI Record Publish Date

March 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-