Pixa 85-10-6431-U

GUDID 00812231033616

Camera, Single Use, 4mm, 30 Deg, EXT Length, Universal

SANTA BARBARA IMAGING SYSTEMS, INC.

Rigid arthroscope, single-use

• Primary Device ID: 00812231033616
• NIH Device Record Key: 314da12e-cee2-48de-9723-d1d1776908ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pixa
• Version Model Number: 85-10-6431-U
• Catalog Number: 85-10-6431-U
• Company DUNS: 065016344
• Company Name: SANTA BARBARA IMAGING SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812231033616 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

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• 00853460007009: Camera Control Unit, Pixa Console with Image Capture & Light Engine
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• 00812231033616: Camera, Single Use, 4mm, 30 Deg, EXT Length, Universal
• 00812231033609: Camera, Single Use, 4mm, 30 Deg, STD Length, Universal
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• 00812231033289: Camera, Single Use, 4MM, 30 DEG, EXT Length, Pixa
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• 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