UNICO ColpoMaster II CS-205LED

GUDID 00816668020065

CS-205LED Colposcope Center Post, Binocular Zoom Head, Five Legged Base. LED Illumination

UNITED PRODUCTS & INSTRUMENTS

Colposcope

• Primary Device ID: 00816668020065
• NIH Device Record Key: 73ccaaea-018b-4675-a178-fbf5aaed6cbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNICO ColpoMaster II
• Version Model Number: CS-205LED
• Catalog Number: CS-205LED
• Company DUNS: 796269165
• Company Name: UNITED PRODUCTS & INSTRUMENTS
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (732)274-1155
• Email: info@unicosci.com
• Phone: (732)274-1155
• Email: info@unicosci.com
• Phone: (732)274-1155
• Email: info@unicosci.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816668020065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073053

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [UNICO ColpoMaster II]

• 00816668020072: CS-205T-LED Colposcope Center Post, Trinocular Zoom Head, Five Legged Base. LED Illumination.
• 00816668020065: CS-205LED Colposcope Center Post, Binocular Zoom Head, Five Legged Base. LED Illumination