FDA.reportPublic FDA data

NA

Primary DI
00613994571939
Brand
NA
Company
MEDTRONIC, INC.
Model
3550-03
Device description
ACC 3550-03 TWIST LOCK SCRN CABLE BOWEL
Published
2014-09-23
Public version status
Update
Distribution status
Not 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
EZWStimulator, electrical, implantable, for incontinence
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
LGWStimulator, spinal-cord, totally implanted for pain relief
MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
NHLSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
PJSStimulator, electrical, implanted, for essential tremor
QONImplanted electrical device intended for treatment of fecal incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3
QONImplanted Electrical Device Intended For Treatment Of Fecal IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080025000MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMMedtronic Neuromodulation2011-03-14QON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994571939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994571939006139945719396139945719390613994571939

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796986144
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812537036915Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-17
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.NHL2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
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
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZB2026-01-19
00812537036021Nalu Medical, Inc.NALU MEDICAL, INC.GZB2024-01-02
00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30
00812537034355Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30
00812537036076Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00812537036083Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00812537036090Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00812537036113Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00812537036120Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00812537036137Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00812537036144Nalu Medical, Inc.NALU MEDICAL, INC.GZB2021-12-10
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
00812537033822Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-10-12
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21