FDA.report

SJM™

Primary DI
05414734500715
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
4071
Catalog number
4071
Device description
TIP INTRODUCER/TORQUE TOOL ACCESSORY KIT
Published
2017-04-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications

CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05414734500715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05414734500715054147345007155414734500715

GMDN Terms

TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
790268031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05414734509138NAST. JUDE MEDICAL, INC.NIK2026-03-04
05414734506380NAST. JUDE MEDICAL, INC.NIK2025-12-22
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067049513Entrant™ST. JUDE MEDICAL, INC.NIK2024-04-25
05415067049520Gallant™ST. JUDE MEDICAL, INC.NIK2024-04-25
00802526589744RESONATE™ HF CRT-DBOSTON SCIENTIFIC CORPORATIONNIK2021-07-12
05415067032829myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
00763000178093Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178109Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178130Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178147Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
04035479140144Itrevia 5 HF-T QPBIOTRONIK SE & Co. KGNIK2020-10-07
00763000059996Compia MRI™ Quad CRT-D SureScan™MEDTRONIC, INC.NIK2020-09-04
00763000060091Compia MRI™ CRT-D SureScan™MEDTRONIC, INC.NIK2020-09-04
05415067032010Gallant™ST. JUDE MEDICAL, INC.NIK2020-09-02
05415067032850Entrant™ST. JUDE MEDICAL, INC.NIK2020-09-02
00763000178178Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178185Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178215Cobalt™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178222Cobalt™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178253Crome™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178260Crome™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178291Crome™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178307Crome™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00643169720732Compia MRI™ CRT-D SureScan™MEDTRONIC, INC.NIK2019-10-14
04035479156725Ilivia Neo 7 HF-T QPBIOTRONIK SE & Co. KGNIK2019-09-10
04035479156732Ilivia Neo 7 HF-TBIOTRONIK SE & Co. KGNIK2019-09-10
04035479156824Intica Neo 7 HF-T QPBIOTRONIK SE & Co. KGNIK2019-09-10