Pixa 85-10-2100

GUDID 00853460007016

Camera Head, Pixa Integrated

SANTA BARBARA IMAGING SYSTEMS, INC.

Endoscope video camera

• Primary Device ID: 00853460007016
• NIH Device Record Key: e821d6b9-67d8-4eab-8847-b8c97f34e9c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pixa
• Version Model Number: 85-10-2100
• Catalog Number: 85-10-2100
• Company DUNS: 065016344
• Company Name: SANTA BARBARA IMAGING SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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	00853460007016 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00853460007016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-22
• Device Publish Date: 2017-12-04

On-Brand Devices [Pixa]

• 00853460007283: Camera Control Unit, Pixa Console 4K with Image Capture
• 00853460007269: Camera Head, Pixa C-Mount, 4K, 3CMOS
• 00853460007245: Camera Head, Pixa Integrated 4K
• 00853460007047: Camera Control Unit, Pixa Console 4K with Image Capture & Light Engine
• 00853460007030: Tablet, Pixa
• 00853460007023: CAMERA HEAD HD C-MOUNT 3CMOS
• 00853460007016: Camera Head, Pixa Integrated
• 00853460007009: Camera Control Unit, Pixa Console with Image Capture & Light Engine
• 00812231031940: Camera Head, Pixa, Integrated, 4K, 1CMOS
• 00812231031933: Camera Head, Pixa, C-Mount, 4K, 1CMOS
• 00812231033616: Camera, Single Use, 4mm, 30 Deg, EXT Length, Universal
• 00812231033609: Camera, Single Use, 4mm, 30 Deg, STD Length, Universal
• 00812231033593: Camera, Single Use, 5.5mm, 30 Deg, STD Length, Universal
• 00812231033289: Camera, Single Use, 4MM, 30 DEG, EXT Length, Pixa
• 00812231033210: Camera, Single Use, 4MM, 30 DEG, STD Length, Pixa
• 00812231033203: Pixa Camera, Single Use, 5.5MM, 30 Deg, STD Length
• 00812231034927: Pixa 4K HDR Tablet, Tethered
• 00812231033937: Pixa 4K HDR, Tablet
• 00812231033890: Pixa 4K HDR System, Camera Head, Integrated, 1C
• 00812231033883: Pixa 4K HDR System, Camera Head, Integrated, 3C
• 00812231033876: Pixa 4K HDR System, Camera Head, C-Mount, 3C
• 00812231033869: Pixa 4K HDR System, Camera Head, C-Mount, 1C
• 00812231033821: Pixa 4K HDR System, Control Unit with Image Capture and Light Engine
• 00812231033852: Pixa 4K HDR System, Camera Head, Guillotine, 3C
• 00812231033845: Pixa 4K HDR System, Camera Head, Guillotine, 1C