Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System 4410-20070-A

GUDID 00840286840989

Femoral Head Impactor, UniSyn

Shalby Advanced Technologies, Inc.

Orthopaedic implant impactor, reusable

• Primary Device ID: 00840286840989
• NIH Device Record Key: 3ca2db02-aeff-4a85-b361-77315d220392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System
• Version Model Number: 4410-20070-A
• Catalog Number: 4410-20070-A
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00840286840989 [Primary]

FDA Product Code

• HWA: Impactor

Sterilization

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

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

[00840286840989]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

Devices Manufactured by Shalby Advanced Technologies, Inc.

• 00840286840453 - TaperSet Hip System: 2025-05-28 TaperSet, Instrument Case
• 00840286840477 - TaperSet Hip System: 2025-05-28 TaperSet, Broach Holder, Assembly
• 00840286840637 - TaperSet Hip System: 2025-05-28 TaperSet, Trial Neck, Lat., Size 5mm & 6mm
• 00840286840644 - TaperSet Hip System: 2025-05-28 TaperSet, Trial Neck, Lat., Size 7.5mm & 9mm
• 00840286840651 - TaperSet Hip System: 2025-05-28 TaperSet, Trial Neck, Lat., Size 10.5mm & 12mm
• 00840286840668 - TaperSet Hip System: 2025-05-28 TaperSet, Trial Neck, Lat., Size 13.5mm & 15mm
• 00840286840675 - TaperSet Hip System: 2025-05-28 TaperSet, Trial Neck, Lat., Size 16.5mm & 18.5mm
• 00840286840682 - TaperSet Hip System: 2025-05-28 TaperSet, Trial Neck, Lat., Size 21mm & 24mm