FDA.reportPublic FDA data

Op.n Core HDMI cable

Primary DI
03701311501466
Brand
Op.n Core HDMI cable
Company
ECENTIAL ROBOTICS
Model
I01018
Published
2025-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242914000Op.n(TM) NavigationEcential Robotics2025-03-07OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701311501466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701311501466037013115014663701311501466

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Regulatory Flags#

DUNS number
261610964
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
037013115004453DSRW SoftwareL000162023-03-01
03701311500995Broach Set SPX1A010212023-09-04
037013115009713D Offset Imaging Set SPX1A010382023-09-04
03701311501015Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mmA010202023-09-04
03701311501039Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mmA010282023-09-04
03701311501053Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mmA010192023-09-04
03701311501077Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mmA010292023-09-04
03701311501121SURGIVISIO DEVICEI010012023-09-04
03701311500322CoBotI000192023-03-01
03701311500407SURGIVISIOI000012023-03-01
03701311501442Op.n Core Power CordI010152025-11-04
03701311501459Op.n Core ethernet cableI010162025-11-04
03701311500032Broach Set SPX1A000212023-03-01
03701311501497Op.n ChoiceSpine AppL600182025-05-15
037013115000183D Imaging Set SPX1A000182023-03-01
037013115003913D Offset Imaging Set SPX1A000382023-03-01
03701311501275Op.n CameraI000262025-03-20
03701311500865Op.n Tracker AA000632025-03-20
03701311500872Op.n Tracker BA000642025-03-20
03701311500889Op.n Tracker CA000652025-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882433ION-C Navigation LocatorSurgentec, LLCOLO2026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSurgentec, LLCOLO2026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSurgentec, LLCOLO2026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSurgentec, LLCOLO2026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSurgentec, LLCOLO2026-07-06
00810131882556TiLink-L Navigation Drill GuideSurgentec, LLCOLO2026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSurgentec, LLCOLO2026-07-06
00810131882617TiLink-L Navigation Impact CapSurgentec, LLCOLO2026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSurgentec, LLCOLO2026-07-06
00810131883669Ion Navigation Inserter AOSurgentec, LLCOLO2026-07-06
00810131884871ION-C Navigation Reusable TraySurgentec, LLCOLO2026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySurgentec, LLCOLO2026-07-06
10705034647845TRIALTISMedos International SàrlOLO2026-07-04
10705034647852TRIALTISMedos International SàrlOLO2026-07-04
10705034647883TRIALTISMedos International SàrlOLO2026-07-04
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08