mahe medical GmbH - TI 3.5mm mono-/polyaxial locking screw, - mahe medical gmbh

Duns Number:342243334

Device Description: TI 3.5mm mono-/polyaxial locking screw, _x000D_L.48mm _x0 TI 3.5mm mono-/polyaxial locking screw, _x000D_L.48mm _x000D_

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More Product Details

Catalog Number

-

Brand Name

mahe medical GmbH

Version/Model Number

150-6635-048PTXL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

-

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

c84d57d3-073e-474b-9834-37cd2d0d2d49

Public Version Date

November 13, 2019

Public Version Number

1

DI Record Publish Date

November 05, 2019

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