MUTARS® proximal femur incl. safety screw

GUDID 04048844045760

implantcast GmbH

Uncoated hip femur prosthesis, modular

• Primary Device ID: 04048844045760
• NIH Device Record Key: d0262f96-483e-46ea-bfa1-9268fe6b9dd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® proximal femur incl. safety screw
• Version Model Number: 57100207
• 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: true
• 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	04048844045760 [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

On-Brand Devices [MUTARS® proximal femur incl. safety screw]

• 04048844045760: 57100207
• 04048844045753: 57100205