EcoFit® hip stem 133° cementless cpTi lateralized

GUDID 04048844256395

implantcast GmbH

Press-fit femoral stem prosthesis

• Primary Device ID: 04048844256395
• NIH Device Record Key: b2f7aa63-9871-442b-8791-f2b4e3cc8066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® hip stem 133° cementless cpTi lateralized
• Version Model Number: 30374112
• 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	04048844256395 [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 lateralized]

• 04048844256449: 30374200
• 04048844256432: 30374175
• 04048844256425: 30374150
• 04048844256418: 30374137
• 04048844256401: 30374125
• 04048844256395: 30374112
• 04048844256388: 30374100
• 04048844256371: 30374087
• 04048844256364: 30374075
• 04048844256357: 30374062
• 04048844407131: 30374187
• 04048844407124: 30374162