Trinity 81-10-1200

GUDID 00853460007344

Tablet User Interface

SANTA BARBARA IMAGING SYSTEMS, INC.

Endoscopic device remote control

• Primary Device ID: 00853460007344
• NIH Device Record Key: 8f55c6f9-1095-4bab-bc9c-870b15d2ed61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity
• Version Model Number: 81-10-1200
• Catalog Number: 81-10-1200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853460007344 [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: 2019-01-18
• Device Publish Date: 2018-12-18

On-Brand Devices [Trinity]

• 00853460007344: Tablet User Interface
• 00853460007337: TRINITY HD Camera Control Unit
• 00853460007313: TRINITY 4K Camera Head 3 CMOS - C-MOUNT
• 00853460007306: TRINITY HD Camera Head 3 CMOS - C-MOUNT
• 00853460007146: TRINITY 4K Camera Head 3 CMOS - Eyecup
• 00853460007139: TRINITY 4K Camera Control Unit
• 00853460007078: Tablet User Interface
• 00853460007061: TRINITY HD Camera Head 3 CMOS - Eyecup
• 00853460007054: TRINITY HD Camera Control Unit