OMNI 83-10-1200

GUDID 00812231033524

Tablet, Hologic, JPN

SANTA BARBARA IMAGING SYSTEMS, INC.

Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control Endoscopic device remote control

• Primary Device ID: 00812231033524
• NIH Device Record Key: 86d03ca4-c8f0-46ce-a3cf-395b51f6a001
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI
• Version Model Number: 83-10-1200
• Catalog Number: 83-10-1200
• Company DUNS: 065016344
• Company Name: SANTA BARBARA IMAGING SYSTEMS, 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: 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

Customer Support Contacts

• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com
• Phone: 805-770-2110
• Email: Info@sbimagingsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812231033524 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2023-03-07
• Device Publish Date: 2023-02-27

On-Brand Devices [OMNI]

• 00812231032978: 4K UHD CAMERA HEAD, INTEGRATED, 1CMOS, HOLOGIC
• 00812231032831: TABLET, HOLOGIC
• 00812231032961: 4K UHD CAMERA CONTROL UNIT
• 00812231032923: ACMI LIGHT GUIDE POST ADAPTER
• 00812231032916: STORZ LIGHT GUIDE POST ADAPTER
• 00812231032909: WOLF LIGHT GUIDE POST ADAPTER
• 00812231032893: 5MM LIGHT GUIDE, BLUE
• 00812231032886: 5MM LIGHT GUIDE, GREY
• 00812231032947: CAMERA HEAD TRAY, HOLOGIC
• 00812231033531: 4K UHD CAMERA CONTROL UNIT, HOLOGIC, JPN
• 00812231033524: Tablet, Hologic, JPN
• 00812231034453: OMNI 4K HDR SYSTEM, TABLET
• 00812231034446: OMNI 4K HDR SYSTEM, CAMERA HEAD, INTEGRATED, 1C
• 00812231034422: OMNI 4K HDR SYSTEM, CAMERA CONTROL UNIT WITH IMAGE CAPTURE & LIGHT ENGINE
• 00812231033470: OMNI 4K HDR SYSTEM, TABLET, TETHERED