MUTARS® rasp for femoral stem

GUDID 04048844124960

implantcast GmbH

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04048844124960
• NIH Device Record Key: efc71080-1907-424e-9174-6f4d23583dc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® rasp for femoral stem
• Version Model Number: 77600117
• 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	04048844124960 [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

[04048844124960]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-30

On-Brand Devices [MUTARS® rasp for femoral stem]

• 04048844124939: 77600114
• 04048844124922: 77600113
• 04048844124915: 77600112
• 04048844242992: 77600119
• 04048844142759: 77600118
• 04048844125585: 77600120
• 04048844124960: 77600117
• 04048844124953: 77600116
• 04048844124946: 77600115