FDA.reportPublic FDA data

N/A

Primary DI
00643169953581
Brand
N/A
Company
MEDTRONIC, INC.
Model
3550-06
Device description
ACCY 3550-06 TUNNELING TOOL US
Published
2018-05-14
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
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

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
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3

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
00643169953581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169953581006431699535816431699535810643169953581

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.

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
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04
00824846003687NABB4K20R42026-07-04
00824846003700NABB4645R212026-07-04
00824846001669NABB12T12R42026-06-28
00824846001843NA9S63R22026-06-28
00824846001850NA11U35R32026-06-28
00824846001614NABB12V43R32026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDQRB2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONQRB2026-06-08
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
00763000520083N/AMEDTRONIC, INC.QRB2021-07-23
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729820826Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820833Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820871Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15