FDA.reportPublic FDA data

NA

Primary DI
00643169015371
Brand
NA
Company
MEDTRONIC, INC.
Model
355531
Device description
CABLE 355531 MULTI-LEAD TRIALING eMAN US
Published
2015-06-08
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
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
GZFSTIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102523000MULTI-LEAD TRIALING CABLE MODEL 355531Medtronic, Inc.2010-10-26GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169015371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169015371006431690153716431690153710643169015371

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.

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
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
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
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10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030194Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21