Hintermann Series H2 - H2 TALAR COMPONENT LEFT - SIZE 1 - Dt Medtech, LLC

Duns Number:080101891

Device Description: H2 TALAR COMPONENT LEFT - SIZE 1

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More Product Details

Catalog Number

402111

Brand Name

Hintermann Series H2

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

K171004

Product Code Details

Product Code

HSN

Product Code Name

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Device Record Status

Public Device Record Key

88223499-630e-4efa-8fa0-581e3eb8c321

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DT MEDTECH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 110
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 52