Mixter grasp.fcps. 90°,5/450mm - Mixter grasp.fcps. 90°,5/450mm - mahe medical gmbh

Duns Number:342243334

Device Description: Mixter grasp.fcps. 90°,5/450mm

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More Product Details

Catalog Number

26.036.45

Brand Name

Mixter grasp.fcps. 90°,5/450mm

Version/Model Number

26.036.45

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FCL

Product Code Name

FORCEPS, BIOPSY, NON-ELECTRIC

Device Record Status

Public Device Record Key

23720840-e6b4-4c26-bfc5-8fe90007640e

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 14, 2018

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