Signature ONE

GUDID 00887868522987

Alliance Glenoid Shoulder Guide and Bone Model Left

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 00887868522987
• NIH Device Record Key: afa5e09b-c658-4a38-a544-b75a68de4065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature ONE
• Version Model Number: 20-8090-008-01
• 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: 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(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868522987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212560

FDA Product Code

• QHE: Shoulder Arthroplasty Implantation System

Sterilization

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

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

[00887868522987]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [Signature ONE]

• 00887868522994: Alliance Glenoid Shoulder Guide and Bone Model Right
• 00887868522987: Alliance Glenoid Shoulder Guide and Bone Model Left