Osteo-P™ Bone Graft Substitute - Osteo-P™ bone graft substitute granules 10 cc - MOLECULAR MATRIX, INC.

Duns Number:064845937

Device Description: Osteo-P™ bone graft substitute granules 10 cc

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More Product Details

Catalog Number

BGS-G10

Brand Name

Osteo-P™ Bone Graft Substitute

Version/Model Number

BGS-G10

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

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

00dd543f-cfc8-46f0-bf04-7ad3601433ca

Public Version Date

January 06, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MOLECULAR MATRIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11