ANATOMICAL SHOULDER™ REVISION

GUDID 00889024387225

X-piece

Zimmer GmbH

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00889024387225
• NIH Device Record Key: 429924c2-52b4-4a9d-bfe8-66081b8d7551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMICAL SHOULDER™ REVISION
• Version Model Number: 01.04558.302
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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: 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@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024387225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142403

FDA Product Code

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

Sterilization

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

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2016-09-24

On-Brand Devices [ANATOMICAL SHOULDER™ REVISION]

• 00889024387317: Screw III - Connector II / III
• 00889024387300: Screw II - Connector I
• 00889024387294: Screw I - Connector I
• 00889024387287: Connector III
• 00889024387270: Connector II
• 00889024387263: Connector I
• 00889024387256: Impactor / Extractor humeral stem
• 00889024387225: X-piece
• 00889024387218: Milling cutter
• 00889024387201: Drill