OMNI

Basic Information

• Brand Name: OMNI
• Primary DI: 00812231032831
• Version / Model: 83-10-1000
• Catalog Number: 83-10-1000
• 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: 2020-08-26
• Public Version: 1
• Public Version Date: 2020-09-03
• Public Version Status: New
• Public Device Record Key: 2ff65e54-2cb6-4bcf-9fcd-ae2672e666e6

Device Description

TABLET, HOLOGIC

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: No

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
61583	Endoscopic device remote control	A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812231032831	GS1
Package	00812231032985	GS1	Remanufactured Label	1	In Commercial Distribution

Customer Contacts

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