MUTARS® safety screw

GUDID 04048844050702

implantcast GmbH

Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw

• Primary Device ID: 04048844050702
• NIH Device Record Key: 3c63251e-c274-48c7-bfdd-198b64460dc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUTARS® safety screw
• Version Model Number: 57901601
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844050702 [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

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