Anatomical Shoulder™ Reverse

GUDID 00889024286214

AS Inverse Humeral PE-Inlay 40-6

Zimmer GmbH

Total reverse shoulder prosthesis

• Primary Device ID: 00889024286214
• NIH Device Record Key: e587d925-0242-4b4c-9f93-52fab7cc4184
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomical Shoulder™ Reverse
• Version Model Number: 01.04223.406
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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@zimmer.com

Device Dimensions

• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024286214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053274

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2017-07-27

On-Brand Devices [Anatomical Shoulder™ Reverse]

• 00889024286214: AS Inverse Humeral PE-Inlay 40-6
• 00889024286207: AS Inverse Humeral PE-Inlay 40-3
• 00889024286191: AS Inverse Humeral PE-Inlay 40-0
• 00889024286184: AS Inverse Humeral PE-Inlay 36-6
• 00889024286177: AS Inverse Humeral PE-Inlay 36-3
• 00889024286160: AS Inverse Humeral PE-Inlay 36-0
• 00889024286153: AS Inverse Glenoid head 40
• 00889024286146: AS Inverse Glenoid head 36
• 00889024286139: AS Inverse Glenoid fixation
• 00889024286122: AS Inverse Humeral Cup, off center +9
• 00889024286115: AS Inverse Humeral Cup, standard +9
• 00889024286108: AS Inverse Humeral Cup, -20 retro
• 00889024286092: AS Inverse Humerus Cup, +20 retro
• 00889024286085: AS Inverse Humeral Cup, -10 retro
• 00889024286078: Anatomical Shoulder™ Reverse, humeral cup, +10°, retro
• 00889024286061: AS Inverse Humeral Cup, off center
• 00889024286054: AS Inverse Humeral Cup, standard