MUTARS® trial extension piece for mod. prox. tibia

GUDID 04048844146382

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844146382
• NIH Device Record Key: 04bfdb63-eb94-4704-bc81-f81259ff68e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® trial extension piece for mod. prox. tibia
• Version Model Number: 77500105
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844146382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181778

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

[04048844146382]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [MUTARS® trial extension piece for mod. prox. tibia]

• 04048844146382: 77500105
• 04048844099800: 77500125