geneX® putty - geneX® Putty consists of an inorganic framework - BIOCOMPOSITES LTD

Duns Number:424382307

Device Description: geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has be geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile.

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More Product Details

Catalog Number

920-002

Brand Name

geneX® putty

Version/Model Number

920-002

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

K073341,K073341

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

15976f39-1029-40f9-9141-148be61b650c

Public Version Date

January 15, 2020

Public Version Number

1

DI Record Publish Date

January 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCOMPOSITES LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 89