naturesQue MaxOss P - Anorganic Bone Mineral - COLLAGEN MATRIX, INC.

Duns Number:176262442

Device Description: Anorganic Bone Mineral

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More Product Details

Catalog Number

-

Brand Name

naturesQue MaxOss P

Version/Model Number

58493

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)

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

NPM

Product Code Name

Bone Grafting Material, Animal Source

Device Record Status

Public Device Record Key

444b086e-ef0a-4486-90e6-cf3e685c26e7

Public Version Date

March 04, 2020

Public Version Number

1

DI Record Publish Date

February 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLLAGEN 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. 457
U Unclassified 14