EcoFit® hip stem 133° cementless cpTi standard

GUDID 04048844256302

implantcast GmbH

Press-fit femoral stem prosthesis

• Primary Device ID: 04048844256302
• NIH Device Record Key: b1201f3b-ca14-4bf9-9751-f4d219e3e386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® hip stem 133° cementless cpTi standard
• Version Model Number: 30373137
• 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	04048844256302 [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® hip stem 133° cementless cpTi standard]

• 04048844256340: 30373200
• 04048844256333: 30373175
• 04048844256326: 30373150
• 04048844256302: 30373137
• 04048844256296: 30373125
• 04048844256289: 30373112
• 04048844256272: 30373100
• 04048844256265: 30373087
• 04048844256258: 30373075
• 04048844256241: 30373062
• 04048844407117: 30373187
• 04048844407100: 30373162