Bi-Ostetic Foam Strip BF2-15X10-01

GUDID 00816125021642

Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. Bi-Ostetic Foam Strip 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. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, composite
Primary Device ID00816125021642
NIH Device Record Key362c5ca2-3064-4817-8577-ba2821b35125
Commercial Distribution StatusIn Commercial Distribution
Brand NameBi-Ostetic Foam Strip
Version Model NumberBF2-15X10-01
Catalog NumberBF2-15X10-01
Company DUNS081067703
Company NameBERKELEY ADVANCED BIOMATERIALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816125021642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-04-08

On-Brand Devices [Bi-Ostetic Foam Strip]

00816125023592Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125023585Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021796Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021789Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021772Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021765Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021758Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021734Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021727Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021710Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021703Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021697Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021680Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021673Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021666Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021659Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021642Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and
00816125021635Bi-Ostetic Foam Strip is a sterile bone graft composed of purified fibrillar Type I collagen and

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