LinkStation MINI 05000-002

GUDID 00816818020457

LinkStation MINI with Australia and New Zealand power cord

ORTHOSENSOR INC

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• Primary Device ID: 00816818020457
• NIH Device Record Key: 9f0d555e-7e41-49e4-9f24-2ffe03085d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LinkStation MINI
• Version Model Number: LinkStation MINI
• Catalog Number: 05000-002
• Company DUNS: 005788130
• Company Name: ORTHOSENSOR INC
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00816818020457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150372

FDA Product Code

• ONN: Intraoperative Orthopedic Joint Assessment Aid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-20

On-Brand Devices [LinkStation MINI]

• 00816818020495: LinkStation MINI with Switzerland power cord
• 00816818020488: LinkStation MINI with Italy power cord
• 00816818020471: LinkStation MINI with United Kingdom and Ireland power cord
• 00816818020464: LinkStation MINI with Continental Europe/ Korea power cord
• 00816818020457: LinkStation MINI with Australia and New Zealand power cord
• 00816818020440: LinkStation MINI with United States and Canada power cord
• 00816818020006: LinkStation MINI with Continental Europe/ Korea power cord and additional label for Korea
• 00816818022536: LinkStation MINI with United States and Canada power cord. Bluetooth only