Biopor® - Medium Malar Right - CEREMED, INC.

Duns Number:626959824

Device Description: Medium Malar Right

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More Product Details

Catalog Number

CMR-4552

Brand Name

Biopor®

Version/Model Number

CMR-4552

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

KKY

Product Code Name

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Device Record Status

Public Device Record Key

bb279d27-ae3b-4865-a87f-b5c70cfc0402

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CEREMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 64