Alliance Non-Cann Ctr Post Drl Gd SSI006727

GUDID 00889024632851

Zimmer, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

• Primary Device ID: 00889024632851
• NIH Device Record Key: 699bb1e3-e258-49bd-80f0-99da58d927c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alliance Non-Cann Ctr Post Drl Gd
• Version Model Number: SSI006727
• Catalog Number: SSI006727
• Company DUNS: 056038268
• Company Name: Zimmer, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024632851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191814

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

[00889024632851]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-06

Devices Manufactured by Zimmer, Inc.

• 00889024648180 - ROSA® Shoulder: 2024-02-29
• 00889024648197 - ROSA® Shoulder: 2024-02-29
• 00889024648203 - ROSA® Shoulder: 2024-02-29
• 00889024625877 - G7 25MM DRILL GUIDE: 2023-12-25
• 00889024657441 - RDCTN HNDL ASSY LRG: 2023-12-25
• 00889024658004 - PIVOTING HUMERAL EM GUIDE: 2023-12-25
• 00889024660571 - 3.5MM BALL HEX SHAFT: 2023-12-25
• 00889024661257 - REAMER ADPT PULLER: 2023-12-25