Catalog Number

309369

Brand Name

Hintermann Series

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 11, 2021

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171004

Product Code

HTZ

Product Code Name

Instrument, Cutting, Orthopedic

Public Device Record Key

a2817871-9ca2-48b0-b2c8-5b92f2e68ecc

Public Version Date

January 12, 2021

Public Version Number

6

DI Record Publish Date

October 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-