EcoFit® trial cup

GUDID 04048844298258

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844298258
• NIH Device Record Key: 5470e0c4-354c-4dde-8658-c692ea5c57a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoFit® trial cup
• Version Model Number: 02203046
• 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 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	04048844298258 [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

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

[04048844298258]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-11-20

On-Brand Devices [EcoFit® trial cup]

• 04048844298258: 02203046
• 04048844298364: 02203068
• 04048844298357: 02203066
• 04048844298340: 02203064
• 04048844298333: 02203062
• 04048844298326: 02203060
• 04048844298319: 02203058
• 04048844298302: 02203056
• 04048844298296: 02203054
• 04048844298289: 02203052
• 04048844298272: 02203050
• 04048844298265: 02203048