mahe medical GmbH - 2.7 TPO SS polyaxial locking plate, - mahe medical gmbh

Duns Number:342243334

Device Description: 2.7 TPO SS polyaxial locking plate, _x000D_right _x0 2.7 TPO SS polyaxial locking plate, _x000D_right _x000D_

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More Product Details

Catalog Number

-

Brand Name

mahe medical GmbH

Version/Model Number

150-6227-260

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

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

3c215906-0f6a-42d2-859a-7aadf8d54871

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