EcoFit® NH cup cementless

GUDID 04048844396817

implantcast GmbH

Acetabular shell

• Primary Device ID: 04048844396817
• NIH Device Record Key: cee8b8b8-c857-4b5a-9311-db6204b565cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® NH cup cementless
• Version Model Number: 0220016800
• 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	04048844396817 [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® NH cup cementless]

• 04048844396817: 0220016800
• 04048844396800: 0220016600
• 04048844396794: 0220015000
• 04048844396299: 0220016400
• 04048844396282: 0220016200
• 04048844396275: 0220016000
• 04048844396268: 0220015800
• 04048844396251: 0220015600
• 04048844396244: 0220015400
• 04048844396237: 0220015200
• 04048844396220: 0220014800
• 04048844396213: 0220014600