TI WIN DR-plate,short,7/3 holes,left, polyaxial - TI WIN DR-plate,short,7/3 holes,left, polyaxial - mahe medical gmbh

Duns Number:342243334

Device Description: TI WIN DR-plate,short,7/3 holes,left, polyaxial

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More Product Details

Catalog Number

150-6600-203

Brand Name

TI WIN DR-plate,short,7/3 holes,left, polyaxial

Version/Model Number

150-6600-203

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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 Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

e2f74d12-e2f3-4706-932b-6319cc71bc29

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAHE MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 1976