K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm

GUDID 04250337118015

Joimax GmbH

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 04250337118015
• NIH Device Record Key: 10a3522f-aae8-4610-9213-c8e9bc1cf304
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mm
• Version Model Number: JKW1515
• Company DUNS: 344267187
• Company Name: Joimax 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04250337118015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192663

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-22
• Device Publish Date: 2021-11-12

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