EvoGraft EBF1-90X22-10

GUDID 00858418003904

EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 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. EvoGraft 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 ID00858418003904
NIH Device Record Key2cce5674-4a3e-4f53-b0bd-fe6558f53c0c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvoGraft
Version Model NumberEBF1-90X22-10
Catalog NumberEBF1-90X22-10
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
GS100858418003904 [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 [EvoGraft]

00858418003935EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003928EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003911EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003904EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003898EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003881EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003874EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003867EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya
00858418003850EvoGraft is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxya

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