UNICO ColpoMaster I CS-105LED

GUDID 00816668020041

CS-105LED Colposcope Articulating Arm, Binocular Zoom Head, Five Legged Base. LED Illumination

UNITED PRODUCTS & INSTRUMENTS

Colposcope

• Primary Device ID: 00816668020041
• NIH Device Record Key: 8a65e86c-ef74-4ba0-ae4a-40012dd59e24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNICO ColpoMaster I
• Version Model Number: CS-105LED
• Catalog Number: CS-105LED
• 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	00816668020041 [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 I]

• 00816668020058: CS-105T-LED Colposcope Articulating Arm, Trinocular Zoom Head, Five Legged Base. LED Illuminatio
• 00816668020041: CS-105LED Colposcope Articulating Arm, Binocular Zoom Head, Five Legged Base. LED Illumination
• 00816668020034: CS-103T-LED Colposcope Articulating Arm, Trinocular Zoom Head, Three Legged Base. LED Illuminati
• 00816668020027: CS-103LED Colposcope Articulating Arm, Binocular Zoom Head, Three Legged Base. LED Illumination