Synthecure 50-010

GUDID 00862835000439

Bone matrix implant, synthetic, non-antimicrobial

Primary Device ID	00862835000439
NIH Device Record Key	d72edd57-732e-4334-a060-d66c5ebeb448
Commercial Distribution Status	In Commercial Distribution
Brand Name	Synthecure
Version Model Number	50-010
Catalog Number	50-010
Company DUNS	014795494
Company Name	AUSTIN MEDICAL VENTURES INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00862835000439 [Primary]

MQV	Filler, Bone Void, Calcium Compound

Steralize Prior To Use	false
Device Is Sterile	true

00862835000415	Calcium Sulfate Bone Void Filler, Medium
00862835000408	Calcium Sulfate Bone Void Filler, Small
00862835000422	Calcium Sulfate Bone Void Filler, Large
00862835000453	Bone Void Filler Kit, 20cc
00862835000446	Bone Void Filler Kit, 5cc
00862835000439	Bone Void Filler Kit, 10cc
00862835000477	Bone Void Filler Kit, 3cc

Mark Image Registration \| Serial	Company Trademark Application Date
SYNTHECURE 97847356 not registered Live/Pending	Austin Medical Ventures Inc. 2023-03-20
SYNTHECURE 73046066 1022073 Live/Registered	B. F. GOODRICH COMPANY, THE 1975-03-07