FDA.reportPublic FDA data

Screwdriver

Primary DI
08031527009629
Brand
Screwdriver
Company
MICROPORT CRM SRL
Model
ICV1204
Catalog number
ICV1204
Device description
MicroPort Screwdriver for active devices
Published
2014-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXYImplantable Pacemaker Pulse-Generator
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXYImplantable Pacemaker Pulse-GeneratorCardiovascular3
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Unknown3
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950029056
P950029127

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950029056CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERMicroPort CRM S.r.l.1997-03-10DXY
P950029127CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKERMicroPort CRM S.r.l.1997-03-10DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031527009629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527009629080315270096298031527009629

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead setscrewA sterile device designed to secure the attached pacing lead terminal(s) in the header connector (connection socket) of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure. It is typically made of high-grade stainless steel or titanium (Ti). The device is typically available in a set of graduated sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
438860859
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00763000181116NAMEDTRONIC, INC.LWP2024-08-30
00763000181130NAMEDTRONIC, INC.LWP2024-08-30
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
00763000181321NAMEDTRONIC, INC.NVZ2021-06-12
00763000181215NAMEDTRONIC, INC.DXY2021-05-14
00763000178338Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178345Cobalt™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178451Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00763000178468Cobalt™ XT VR MRI SureScan™MEDTRONIC, INC.NVZ2020-11-22
00643169720589Evera MRI™ S VR SureScan®MEDTRONIC, INC.NVZ2020-11-13
04035479147686Evity 6 DR-TBIOTRONIK SE & Co. KGNVZ2020-09-15
00763000060060Visia AF MRI™ S VR SureScan™MEDTRONIC, INC.NVZ2020-09-04
00763000178390Cobalt™ DR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000178499Cobalt™ VR MRI SureScan™MEDTRONIC, INC.NVZ2020-06-08
00763000304942MyCareLink™MEDTRONIC, INC.NVZ2020-03-16
00763000304959MyCareLink™MEDTRONIC, INC.NVZ2020-03-16
00763000304966MyCareLink™MEDTRONIC, INC.NVZ2020-03-16
00643169552272MyCareLink™MEDTRONIC, INC.NVZ2019-08-11
00763000059477NAMEDTRONIC, INC.DXY2018-12-28
00763000059477NAMEDTRONIC, INC.NVZ2018-12-28
00763000060428NAMEDTRONIC, INC.NVZ2018-12-16
00643169634589Azure™ XT DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634602Azure™ S DR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02
00643169634626Azure™ XT SR MRI SureScan™MEDTRONIC, INC.LWP2017-12-02
00643169634640Azure™ S SR MRI SureScan™MEDTRONIC, INC.NVZ2017-12-02