EcoFit®

GUDID 04048844632915

short stem cementless standard cpTi

implantcast GmbH

Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis Press-fit femoral stem prosthesis

• Primary Device ID: 04048844632915
• NIH Device Record Key: ba009f2f-cd99-43cd-9d60-c8e61bb6bac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit®
• Version Model Number: 30321625
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844632915 [Primary]

FDA Product Code

• OQI: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-14
• Device Publish Date: 2024-06-06

On-Brand Devices [EcoFit®]

• 04048844632946: short stem cementless lateralized cpTi
• 04048844632939: short stem cementless lateralized cpTi
• 04048844632922: short stem cementless standard cpTi
• 04048844632915: short stem cementless standard cpTi
• 04048844580155: broach for short stem 133°
• 04048844580148: broach for short stem 133°