MUTARS® connecting part proximal

GUDID 04048844125363

implantcast GmbH

Sleeve femoral/tibial extension, uncoated

• Primary Device ID: 04048844125363
• NIH Device Record Key: fd048f28-ba4c-4664-b56d-3c4c92cd6d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® connecting part proximal
• Version Model Number: 5730010002
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844125363 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-15
• Device Publish Date: 2019-04-05

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