BRAINPRO - 41778C - Pajunk GmbH Medizintechnologie

Duns Number:317654283

Device Description: 41778C

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More Product Details

Catalog Number

41778C

Brand Name

BRAINPRO

Version/Model Number

41778C

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

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

105ea786-5158-4245-b0d3-7c5ea5099105

Public Version Date

November 19, 2021

Public Version Number

6

DI Record Publish Date

April 02, 2021

Additional Identifiers

Package DI Number

04048223108840

Quantity per Package

5

Contains DI Package

04048223098981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PAJUNK GMBH MEDIZINTECHNOLOGIE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 979