TaperSet Hip System/Consensus Hip System/UniSyn Hip System 0908-3-3201

GUDID 00840286840835

Femoral Head Trial, 32mm, -4

Shalby Advanced Technologies, Inc.

Femoral head prosthesis trial
Primary Device ID00840286840835
NIH Device Record Key9366a3d4-a710-4010-9348-ea67223967c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTaperSet Hip System/Consensus Hip System/UniSyn Hip System
Version Model Number0908-3-3201
Catalog Number0908-3-3201
Company DUNS085976260
Company NameShalby Advanced Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
Phone+1(916)355-7100
Emailkhansen@consensusortho.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840286840835 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


[00840286840835]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-28
Device Publish Date2025-05-20

On-Brand Devices [TaperSet Hip System/Consensus Hip System/UniSyn Hip System]

00840286840927Femoral Head Trial, 36mm, +5mm
00840286840941Femoral Head Trial, 36mm, +10mm
00840286840934Femoral Head Trial, 36mm, +8
00840286840910Femoral Head Trial, 36mm, +4
00840286840903Femoral Head Trial, 36mm, Neutral
00840286840897Femoral Head Trial, 36mm, -4
00840286840880Femoral Head Trial, 36mm, -5mm
00840286840873Femoral Head Trial, 32mm, +10mm
00840286840866Femoral Head Trial, 32mm, +5mm
00840286840859Femoral Head Trial, 32mm, +7
00840286840842Femoral Head Trial, 32mm, +4
00840286840835Femoral Head Trial, 32mm, -4
00840286840828Femoral Head Trial, 32mm, Neutral
00840286840811Femoral Head Trial, 32mm, -5mm
00840286840804Femoral Head Trial, 28mm, +3.5mm
00840286840798Femoral Head Trial, 28mm, -3.5mm
00840286840781Femoral Head Trial, 28mm, +10mm
00840286840774Femoral Head Trial, 28mm, +5mm
00840286840767Femoral Head Trial, 28mm, Neutral
00840286840750Femoral Head Trial, 28mm, -5mm

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