DBX® - DBX Mix, 20cc - Musculoskeletal Transplant Foundation, Inc.

Duns Number:187560545

Device Description: DBX Mix, 20cc

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More Product Details

Catalog Number

058200

Brand Name

DBX®

Version/Model Number

058200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In ICCBBA

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)

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

GXP

Product Code Name

Methyl Methacrylate For Cranioplasty

Device Record Status

Public Device Record Key

39468716-1cfb-481f-9a81-bf0be5845c47

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MUSCULOSKELETAL TRANSPLANT FOUNDATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 42