EcoFit® short stem standard cementless cpTi

GUDID 04048844322007

implantcast GmbH

Press-fit femoral stem prosthesis

• Primary Device ID: 04048844322007
• NIH Device Record Key: d24d2ae5-c741-45a1-86fc-54726e702fe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® short stem standard cementless cpTi
• Version Model Number: 30320200
• 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	04048844322007 [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 standard cementless cpTi]

• 04048844322007: 30320200
• 04048844321994: 30320175
• 04048844321987: 30321500
• 04048844321970: 30321375
• 04048844321963: 30320125
• 04048844321956: 30321125
• 04048844321949: 30320100
• 04048844321932: 30320875
• 04048844321925: 30320075
• 04048844321918: 30320625