Signature™ Comprehensive® 20-8090-009-01

GUDID 00887868554391

Orthosoft Inc

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 00887868554391
• NIH Device Record Key: 8d7e1c34-d93b-4f04-b150-037a92471679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature™ Comprehensive®
• Version Model Number: 20-8090-009-01
• Catalog Number: 20-8090-009-01
• Company DUNS: 205670032
• Company Name: Orthosoft Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868554391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232425

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00887868554391]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-19
• Device Publish Date: 2024-02-09

On-Brand Devices [Signature™ Comprehensive®]

• 00887868554407: 20-8090-009-02
• 00887868554391: 20-8090-009-01