EcoFit® cup cementless incl. central hole cover

GUDID 04048844005450

implantcast GmbH

Acetabular shell

• Primary Device ID: 04048844005450
• NIH Device Record Key: 3dd580c9-b618-4a26-8f70-1c4801a0979a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® cup cementless incl. central hole cover
• Version Model Number: 02200064
• Company DUNS: 324369826
• Company Name: implantcast 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844005450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163577

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, 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: 2018-07-06
• Device Publish Date: 2017-10-31

On-Brand Devices [EcoFit® cup cementless incl. central hole cover]

• 04048844005474: 02200068
• 04048844005467: 02200066
• 04048844005450: 02200064
• 04048844005443: 02200062
• 04048844005436: 02200060
• 04048844005429: 02200058
• 04048844005412: 02200056
• 04048844005405: 02200054
• 04048844005399: 02200052
• 04048844005382: 02200050
• 04048844005375: 02200048
• 04048844005368: 02200046