Anatomical Shoulder™ Combined

GUDID 00889024287884

AS™ B/F® adaptor 48°

Zimmer GmbH

Total shoulder prosthesis

• Primary Device ID: 00889024287884
• NIH Device Record Key: 737cd8a2-452c-44b7-8be9-e19cb06b5759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomical Shoulder™ Combined
• Version Model Number: 01.04250.048
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Angle: 48 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024287884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103404

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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™ Combined]

• 00889024481244: AS™ B/F® ADAPTOR 48°
• 00889024481237: AS™ B/F® ADAPTOR 45°
• 00889024481220: AS™ B/F® ADAPTOR 42°
• 00889024287884: AS™ B/F® adaptor 48°
• 00889024287877: AS™ B/F® adaptor 45°
• 00889024287860: AS™ B/F® adaptor 42°