FDA.reportPublic FDA data

ZEOS

Primary DI
00812231030912
Brand
ZEOS
Company
SANTA BARBARA IMAGING SYSTEMS, INC.
Model
84-14-2000
Catalog number
84-14-2000
Device description
C-MOUNT ARTHROSCOPE, 1.9MM 0DEG
Published
2018-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812231031469PackageGS11In Commercial Distribution
00812231031537PackageGS11In Commercial Distribution
00812231030912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812231031469008122310314698122310314690812231031469
00812231031537008122310315378122310315370812231031537
00812231030912008122310309128122310309120812231030912

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.

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
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
00812231031438ZEOS84-14-55482025-04-10
00812231034170ZEOS84-24-64302026-01-19
00812231034941ZEOS84-24-64312026-01-19
00812231033814Pixa85-10-50002025-12-09
00812231033456ZEOS84-10-1500T2025-01-09

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Primary DI, Brand, Company table
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00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
08809281659387BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2026-05-11
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
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08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
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08800038057913MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057920MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057937MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
08800038057944MEDINAUT-I(ICD System)IMEDICOM CO., LTD.HRX2024-02-22
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08800038056305SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056312SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31
08800038056329SYNTH™ BESIMEDICOM CO., LTD.HRX2023-10-31