Inverse/Reverse

GUDID 00889024286016

Inverse/Reverse screw system, 4.5-33

Zimmer GmbH

Total reverse shoulder prosthesis

• Primary Device ID: 00889024286016
• NIH Device Record Key: bd6fd7cd-7679-46fc-9790-595d35e7c6df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inverse/Reverse
• Version Model Number: 01.04223.033
• 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

• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024286016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052906

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-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: 2015-10-16

On-Brand Devices [Inverse/Reverse]

• 00889024286047: Inverse/Reverse screw system, 4.5-48
• 00889024286030: Inverse/Reverse screw system, 4.5-42
• 00889024286023: Inverse/Reverse screw system, 4.5-36
• 00889024286016: Inverse/Reverse screw system, 4.5-33
• 00889024286009: Inverse/Reverse screw system, 4.5-30
• 00889024285996: Inverse/Reverse screw system, 4.5-27
• 00889024285989: Inverse/Reverse screw system, 4.5-24
• 00889024285972: Inverse/Reverse screw system, 4.5-18