B-GENIN Strip - B-GENIN is a bone void filler consisting of - BERKELEY ADVANCED BIOMATERIALS, LLC

Duns Number:081067703

Device Description: B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bon B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone.B-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed blood prior to use at the physician's discretion.

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More Product Details

Catalog Number

BG2-50X15-06

Brand Name

B-GENIN Strip

Version/Model Number

BG2-50X15-06

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113791

Product Code Details

Product Code

MBP

Product Code Name

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Device Record Status

Public Device Record Key

39c4e443-6a9d-4ad6-9eb5-0e1cebfd9c2f

Public Version Date

December 23, 2019

Public Version Number

5

DI Record Publish Date

April 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERKELEY ADVANCED BIOMATERIALS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 178