UniSyn Hip System 3473-62600-A

GUDID 00840286837880

Body, Calcar, Cementless, PC, HA Coated, 26mm

Shalby Advanced Technologies, Inc.

Revision coated hip femur prosthesis
Primary Device ID00840286837880
NIH Device Record Keyec7c4934-f0c1-4eba-87f8-a69ebade27b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniSyn Hip System
Version Model Number3473-62600-A
Catalog Number3473-62600-A
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com
Phone+1(916)355-7100
Emailkhansen@consensusortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286837880 [Primary]

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-31
Device Publish Date2022-01-22

On-Brand Devices [UniSyn Hip System]

00840286837903Body, Calcar, Cementless, PC, HA Coated, 30mm
00840286837897Body, Calcar, Cementless, PC, HA Coated, 28mm
00840286837880Body, Calcar, Cementless, PC, HA Coated, 26mm
00840286837873Body, Calcar, Cementless, PC, HA Coated, 24mm
00840286837866Body, Calcar, Cementless, PC, HA Coated, 22mm
00840286837859Body, Calcar, Cementless, PC, Plasma, 30mm
00840286837842Body, Calcar, Cementless, PC, Plasma, 30mm
00840286837835Body, Calcar, Cementless, PC, Plasma, 28mm
00840286837828Body, Calcar, Cementless, PC, Plasma, 28mm
00840286837811Body, Calcar, Cementless, PC, Plasma, 26mm
00840286837804Body, Calcar, Cementless, PC, Plasma, 26mm
00840286837798Body, Calcar, Cementless, PC, Plasma, 24mm
00840286837781Body, Calcar, Cementless, PC, Plasma, 24mm
00840286837774Body, Calcar, Cementless, PC, Plasma, 22mm
00840286837767Body, Calcar, Cementless, PC, Plasma, 22mm
00840286837750Body, Calcar, Cementless, NP, Grit Blast, 30mm
00840286837743Body, Calcar, Cementless, NP, Grit Blast, 28mm
00840286837736Body, Calcar, Cementless, NP, Grit Blast, 26mm
00840286837729Body, Calcar, Cementless, NP, Grit Blast, 24mm
00840286837712Body, Calcar, Cementless, NP, Grit Blast, 22mm
00840286837705Body, Standard, Cementless, PC, HA/Plasma, 32mm, 38mm
00840286837699Body, Standard, Cementless, PC, HA/Plasma, 32mm, 34mm
00840286837682Body, Standard, Cementless, PC, HA/Plasma, 32mm, 30mm
00840286837675Body, Standard, Cementless, PC, HA/Plasma, 30mm, 38mm
00840286837668Body, Standard, Cementless, PC, HA/Plasma, 30mm, 34mm
00840286837651Body, Standard, Cementless, PC, HA/Plasma, 30mm, 30mm
00840286837644Body, Standard, Cementless, PC, HA/Plasma, 30mm, 26mm
00840286837637Body, Standard, Cementless, PC, HA/Plasma, 28mm, 34mm
00840286837620Body, Standard, Cementless, PC, HA/Plasma, 28mm, 30mm
00840286837613Body, Standard, Cementless, PC, HA/Plasma, 28mm, 26mm
00840286837606Body, Standard, Cementless, PC, HA/Plasma, 26mm, 34mm
00840286837590Body, Standard, Cementless, PC, HA/Plasma, 26mm, 30mm
00840286837583Body, Standard, Cementless, PC, HA/Plasma, 26mm, 26mm
00840286837576Body, Standard, Cementless, PC, HA/Plasma, 26mm, 22mm
00840286837569Body, Standard, Cementless, PC, HA/Plasma, 24mm, 34mm
00840286837552Body, Standard, Cementless, PC, HA/Plasma, 24mm, 30mm
00840286837545Body, Standard, Cementless, PC, HA/Plasma, 24mm, 26mm
00840286837538Body, Standard, Cementless, PC, HA/Plasma, 24mm, 22mm
00840286837521Body, Standard, Cementless, PC, HA/Plasma, 22mm, 30mm
00840286837514Body, Standard, Cementless, PC, HA/Plasma, 22mm, 26mm
00840286837507Body, Standard, Cementless, PC, HA/Plasma, 22mm, 22mm
00840286837491Body, Standard, Cementless, PC, Plasma, 32mm, 38mm
00840286837484Body, Standard, Cementless, PC, Plasma, 32mm, 34mm
00840286837477Body, Standard, Cementless, PC, Plasma, 32mm, 30mm
00840286837460Body, Standard, Cementless, PC, Plasma, 30mm, 38mm
00840286837453Body, Standard, Cementless, PC, Plasma, 30mm, 34mm
00840286837446Body, Standard, Cementless, PC, Plasma, 30mm, 34mm
00840286837439Body, Standard, Cementless, PC, Plasma, 30mm, 30mm
00840286837422Body, Standard, Cementless, PC, Plasma, 30mm, 30mm
00840286837415Body, Standard, Cementless, PC, Plasma, 30mm, 26mm

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