FDA.reportPublic FDA data

N/A

Primary DI
00643169953697
Brand
N/A
Company
MEDTRONIC, INC.
Model
3550-45
Device description
ACCY 3550-45 DBS 4 IN OZ TORQUE WRENCH
Published
2018-04-29
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
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
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
SGSDeep Brain Stimulation for the treatment of Dystonia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3
SGSDeep Brain Stimulation For The Treatment Of DystoniaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840001377

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840001377ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169953697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169953697006431699536976431699536970643169953697

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-34 Degrees Celsius57 Degrees Celsius
Storage Environment Temperature-30 Degrees Fahrenheit135 Degrees Fahrenheit

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
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.SGS2026-05-29
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729820826Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820833Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820871Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15