EcoFit® cup cementless

GUDID 04048844394806

implantcast GmbH

Acetabular shell

• Primary Device ID: 04048844394806
• NIH Device Record Key: 8e1935e7-17b7-4942-86d7-0dc872b89f56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® cup cementless
• Version Model Number: 0220005800
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844394806 [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]

• 04048844397135: 0220006000
• 04048844395834: 0220006600
• 04048844395810: 0220005600
• 04048844395803: 0220005200
• 04048844395797: 0220005000
• 04048844394837: 0220006800
• 04048844394820: 0220006400
• 04048844394813: 0220006200
• 04048844394806: 0220005800
• 04048844394790: 0220005400
• 04048844394783: 0220004800
• 04048844394776: 0220004600