EcoFit® NH cup cementless incl. central hole cover

GUDID 04048844100346

implantcast GmbH

Acetabular shell

• Primary Device ID: 04048844100346
• NIH Device Record Key: a7c39721-a188-4300-ac7e-8e6b028c6f38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® NH cup cementless incl. central hole cover
• Version Model Number: 02200148
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844100346 [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 incl. central hole cover]

• 04048844100445: 02200168
• 04048844100438: 02200166
• 04048844100421: 02200164
• 04048844100414: 02200162
• 04048844100407: 02200160
• 04048844100391: 02200158
• 04048844100384: 02200156
• 04048844100377: 02200154
• 04048844100360: 02200152
• 04048844100353: 02200150
• 04048844100346: 02200148
• 04048844100339: 02200146