FDA.reportPublic FDA data

N/A

Primary DI
00643169986473
Brand
N/A
Company
MEDTRONIC, INC.
Model
355560
Device description
ACCY KIT 355560 SCS EXTNSION PASSER 60CM
Published
2018-09-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000105000MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),Medtronic Vascular2000-04-12GZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169986473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169986473006431699864736431699864730643169986473

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537035932Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-19
00812537036915Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-17
00812537030272Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537030296Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537030883Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537036953Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
0081253703743125cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
0081253703744840cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537037141TD2 Limb CuffNALU MEDICAL, INC.GZB2026-02-25
00812537037158TD2 Thigh WrapNALU MEDICAL, INC.GZB2026-02-25
00812537037165TD2 Relief Belt, LargeNALU MEDICAL, INC.GZB2026-02-25
00812537037172TD2 Relief Belt, SmallNALU MEDICAL, INC.GZB2026-02-25
00812537037257Charger KitNALU MEDICAL, INC.GZB2026-02-25
00812537036984Base Station ChargerNALU MEDICAL, INC.GZB2026-02-24
00812537037127TD2 Patient KitNALU MEDICAL, INC.GZB2026-02-20
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZB2026-01-19
00812537037134TD2 Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537037660Nalu Medical, Inc.NALU MEDICAL, INC.GZB2025-12-08
00812537037189Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037202Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037219Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037332Nalu MedicalNALU MEDICAL, INC.GZB2024-05-01
00812537037349Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537037356Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-05-01
00812537036021Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-01-02
00812537036854Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537036861Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27