FDA.reportPublic FDA data

ZEOS

Primary DI
00812231034026
Brand
ZEOS
Company
SANTA BARBARA IMAGING SYSTEMS, INC.
Model
84-10-4121
Device description
ZEOS CAMERA HEAD, GUILLOTINE, 4K, 1CMOS
Published
2023-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812231034064PackageGS11In Commercial Distribution
00812231034071PackageGS11In Commercial Distribution
00812231034026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812231034064008122310340648122310340640812231034064
00812231034071008122310340718122310340710812231034071
00812231034026008122310340268122310340260812231034026

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
805-770-2110Info@sbimagingsystems.com

Regulatory Flags#

DUNS number
065016344
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812231033906Pixa85-10-64322026-06-08
00812231033913Pixa85-10-64332026-06-08
00812231033920Pixa85-10-65322026-06-08
00812231034095Pixa85-10-64722026-06-08
00812231034101Pixa85-10-64732026-06-08
00812231032886OMNI83-20-500283-20-50022020-09-17
00812231032893OMNI83-20-500383-20-50032020-09-17
00853460007153Imaging (ZEOS)84-20-500484-20-50042018-12-03
00853460007160Imaging (ZEOS)84-20-500584-20-50052018-12-03
00812231030349ZEOS84-20-500284-20-50022018-08-23
00812231030356ZEOS84-20-500384-20-50032018-08-30
00812231034323ZEOS84-10-64322026-01-19
00812231034330ZEOS84-10-64332026-01-19
00812231034347ZEOS84-10-65322026-01-19
00812231034354ZEOS84-10-64722026-01-19
00812231034361ZEOS84-10-64732026-01-19
00812231034859ZEOS84-10-64362026-01-19
00812231034866ZEOS84-10-64372026-01-19
00812231034873ZEOS84-10-64762026-01-19
00812231034880ZEOS84-10-64772026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24