Consensus Hip System/UniSyn Hip System 4410-10020-A

GUDID 00840286841597

Slap Hammer, UniSyn

Shalby Advanced Technologies, Inc.

Orthopaedic implant impactor, reusable

• Primary Device ID: 00840286841597
• NIH Device Record Key: 7b40f3cc-0c2d-4e50-87b0-f56faebd99cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consensus Hip System/UniSyn Hip System
• Version Model Number: 4410-10020-A
• Catalog Number: 4410-10020-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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286841597 [Primary]

FDA Product Code

• FZY: Hammer, Surgical

Sterilization

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

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

[00840286841597]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-30
• Device Publish Date: 2025-05-22

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

• 00840286841597: Slap Hammer, UniSyn
• 00840286841580: 8mm Starter Drill, UniSyn