TaperSet Hip System/Consensus Hip System/UniSyn Hip System 0908-3-3601

GUDID 00840286840897

Femoral Head Trial, 36mm, -4

Shalby Advanced Technologies, Inc.

Femoral head prosthesis trial

• Primary Device ID: 00840286840897
• NIH Device Record Key: 9ff0f106-5e8f-4fb3-a33c-2453203862b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TaperSet Hip System/Consensus Hip System/UniSyn Hip System
• Version Model Number: 0908-3-3601
• Catalog Number: 0908-3-3601
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286840897 [Primary]

FDA Product Code

• HWT: Template

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

[00840286840897]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

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

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