EcoFit® 133° trial neck lateralised for broach 133°

GUDID 04048844310158

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844310158
• NIH Device Record Key: a82989f4-d41b-49d0-935b-1afd78d05da5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® 133° trial neck lateralised for broach 133°
• Version Model Number: 70601214
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844310158 [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: true
• Device Is Sterile: false

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

[04048844310158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-04
• Device Publish Date: 2019-03-27

Devices Manufactured by implantcast GmbH

• 04048844049881 - MUTARS®: 2024-11-15 femoral stem cemented
• 04048844049898 - MUTARS®: 2024-11-15 femoral stem cemented
• 04048844049911 - MUTARS®: 2024-11-15 femoral stem cemented
• 04048844049928 - MUTARS®: 2024-11-15 femoral stem cemented
• 04048844049942 - MUTARS®: 2024-11-15 femoral stem cemented
• 04048844049959 - MUTARS®: 2024-11-15 femoral stem cemented
• 04048844042844 - n/a: 2024-10-08 modular handle 'fast fix'
• 04048844043032 - n/a: 2024-10-08 femoral/tibial extractor