FDA.reportPublic FDA data

ORCHESTRA PLUS LINK

Primary DI
08031527014210
Brand
ORCHESTRA PLUS LINK
Company
MICROPORT CRM SRL
Model
None
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031527014210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527014210080315270142108031527014210

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator programmerAn external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
438860859
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08031527013909ECG Cable4,5m2014-09-05
08031527013916ECG Cable3m2014-09-05
08031527015057SPIDERVIEW / SPIDERFLASH2 Leads / 3E2016-09-22
08031527015064SPIDERVIEWXYZ-HR / 7E2016-09-22
08031527015071SPIDERVIEW12 Leads / 10 E2016-09-22
08031527015088SPIDERVIEW2 Leads / 5 E2016-09-22
08031527015095SPIDERVIEW3 Leads XYZ / 7E2016-09-22
08031527016023SPIDERVIEW7 leads2016-09-22
08031527019789VegaTLD040UTLD040U2023-06-23
08031527019796VegaTLD041UTLD041U2023-06-23
08031527019802VegaTLD042UTLD042U2023-06-23
08031527019611CPR4B10031B100312023-06-26
08031527019819VegaRLK40URLK40U2023-06-26
08031527019826VegaRLK41URLK41U2023-06-26
08031527019833VegaRLK42URLK42U2023-06-26
08031527018997BlueSkyTPM020UTPM020U2023-06-23
08031527019000BlueSkyTPM021UTPM021U2023-06-23
08031527019017BlueSkyTPM024UTPM024U2023-06-23
08031527019024BlueSkyTPM025UTPM025U2023-06-23
08031527019932SmartViewSW001USW001U2023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812058NAMEDTRONIC, INC.NVZ2025-04-12
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.NVZ2024-11-13
00763000378356Instrument Command LibraryMEDTRONIC, INC.NVZ2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.NVZ2024-05-04
04035479173937Solvia Rise SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173944Solvia Rise DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
00763000612658MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000612665MyCareLink™MEDTRONIC, INC.NVZ2023-05-13
00763000688400CareLink SmartSync™MEDTRONIC, INC.NVZ2022-10-28
00763000688479NAMEDTRONIC, INC.NVZ2022-10-28
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000181345NAMEDTRONIC, INC.NVZ2021-06-12
00763000316709Azure™ XT SR MRI SureScan™MEDTRONIC, INC.NVZ2021-02-25
00763000414023MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414030MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000414047MyCareLink™MEDTRONIC, INC.NVZ2021-02-07
00763000316693Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316716Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316846Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2021-01-08
00763000316723Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316730Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316747Adapta™ SMEDTRONIC, INC.NVZ2020-11-28
00763000316761Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316778Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316785Adapta™MEDTRONIC, INC.NVZ2020-11-28
00763000316792Adapta™MEDTRONIC, INC.NVZ2020-11-28