Linkstation MINI Evaluation Kit 05000-500

GUDID 00816818020501

LinkStation MINI Evaluation Kit with power cord for United States and Canada

ORTHOSENSOR INC

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• Primary Device ID: 00816818020501
• NIH Device Record Key: e863442a-282c-4eb9-b707-477c4aea24d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Linkstation MINI Evaluation Kit
• Version Model Number: Linkstation MINI Evaluation Kit
• Catalog Number: 05000-500
• 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	00816818020501 [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 Evaluation Kit]

• 00816818020563: LinkStation MINI Evaluation Kit with Continental Europe/ Korea power cord and additional label f
• 00816818020556: LinkStation MINI Evaluation Kit with Switzerland power cord
• 00816818020549: LinkStation MINI Evaluation Kit with Italy power cord
• 00816818020532: LinkStation MINI Evaluation Kit with United Kingdom and Ireland power cord
• 00816818020525: LinkStation MINI Evaluation Kit with Continental Europe power cord
• 00816818020518: LinkStation MINI Evaluation Kit with Australia and New Zealand power cord
• 00816818020501: LinkStation MINI Evaluation Kit with power cord for United States and Canada
• 00816818022635: LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth only.