Pixa

Basic Information

• Brand Name: Pixa
• Primary DI: 00853460007252
• Version / Model: 85-10-4110
• Catalog Number: 85-10-4110
• Company Name: SANTA BARBARA IMAGING SYSTEMS, INC.
• Labeler DUNS: 065016344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-30
• Public Version: 2
• Public Version Date: 2020-07-03
• Public Version Status: Update
• Public Device Record Key: 5d035c05-2225-44f2-b2aa-604f42fe31a2

Device Description

Camera Head, Pixa, C-Mount, 4K, 1CMOS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00812231031933	GS1	SNS	1	In Commercial Distribution
Primary	00853460007252	GS1
Package	00853460007603	GS1	Service	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]