FDA.reportPublic FDA data

NA

Primary DI
00643169887565
Brand
NA
Company
MEDTRONIC, INC.
Model
355538
Device description
ACCY KIT 355538 EXTN PASSER 38CM FWU
Published
2017-09-09
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)

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
00643169887565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169887565006431698875656431698875650643169887565

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
796986144
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537037752Nalu™ User Trial KitNALU MEDICAL, INC.GZB2026-05-27
0081253703743125cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
0081253703744840cm Straight StyletNALU MEDICAL, INC.GZB2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537037691Lead Kit (4 Contact, 25cm, Tined)NALU MEDICAL, INC.GZB2026-02-26
00812537037707Lead Kit (4-Contact, 40cm, Tined)NALU 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
00812537036878Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537036885Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-10-27
00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30