AnatomyPrint - Anatomy Print Model BJ - Materialise NV

Duns Number:373139427

Device Description: Anatomy Print Model BJ

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More Product Details

Catalog Number

ANA-MA10-00-05

Brand Name

AnatomyPrint

Version/Model Number

ANA-MA10-00-05

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2018

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

84c63690-e0e6-431f-b5f5-9943823e6fa1

Public Version Date

November 27, 2019

Public Version Number

4

DI Record Publish Date

July 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MATERIALISE NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 296