EcoFit® short stem lateralized cementless cpTi

GUDID 04048844322014

implantcast GmbH

Press-fit femoral stem prosthesis

• Primary Device ID: 04048844322014
• NIH Device Record Key: 12f1f987-d720-4ed3-867d-b73529f12121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® short stem lateralized cementless cpTi
• Version Model Number: 30420625
• 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 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	04048844322014 [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® short stem lateralized cementless cpTi]

• 04048844322106: 30420200
• 04048844322090: 30420175
• 04048844322083: 30421500
• 04048844322076: 30421375
• 04048844322069: 30420125
• 04048844322052: 30421125
• 04048844322045: 30420100
• 04048844322038: 30420875
• 04048844322021: 30420075
• 04048844322014: 30420625