ACS® Uni trial femoral component

GUDID 04048844487195

implantcast GmbH

Knee femur prosthesis trial

• Primary Device ID: 04048844487195
• NIH Device Record Key: 00c13393-7efd-4e20-95b4-42807ef7eb83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACS® Uni trial femoral component
• Version Model Number: 42160354
• 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: 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 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 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	04048844487195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203341

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

[04048844487195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-15

On-Brand Devices [ACS® Uni trial femoral component]

• 04048844487195: 42160354
• 04048844487188: 42160353
• 04048844487171: 42160352
• 04048844487164: 42160351