plug

GUDID 04048844108533

implantcast GmbH

Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug Acetabulum prosthesis hole plug

• Primary Device ID: 04048844108533
• NIH Device Record Key: f7cc1912-5ee7-4f1c-9d11-a39d47720f5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: plug
• Version Model Number: 02200001
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844108533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163577

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-31

Devices Manufactured by implantcast GmbH

• 04048844522810 - AGILON®: 2024-02-29 metaphyseal component trauma incl. safety screw
• 04048844522827 - AGILON®: 2024-02-29 metaphyseal component trauma
• 04048844522834 - AGILON®: 2024-02-29 metaphyseal component omarthrosis incl. safety screw
• 04048844522841 - AGILON®: 2024-02-29 metaphyseal component omarthrosis
• 04048844522858 - AGILON®: 2024-02-29 metaphyseal component omarthrosis incl. safety screw
• 04048844522865 - AGILON®: 2024-02-29 metaphyseal component omarthrosis
• 04048844522902 - AGILON®: 2024-02-29 trial metaphyseal component trauma 145°
• 04048844522919 - AGILON®: 2024-02-29 trial metaphyseal component omarthrosis 145°