Synthecure 50-020

GUDID 00862835000453

Bone Void Filler Kit, 20cc

AUSTIN MEDICAL VENTURES INC.

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID00862835000453
NIH Device Record Key16235671-926d-4fcb-808f-e9ee23a4e17d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynthecure
Version Model Number50-020
Catalog Number50-020
Company DUNS014795494
Company NameAUSTIN MEDICAL VENTURES INC.
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com
Phone901-748-2581
Emailinfo@synthecure.com

Device Dimensions

Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram
Weight25 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS100862835000453 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-13
Device Publish Date2022-05-05

On-Brand Devices [Synthecure]

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

Trademark Results [Synthecure]

Mark Image

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