FDA.reportPublic FDA data

Itrel® 4

Primary DI
00643169107809
Brand
Itrel® 4
Company
MEDTRONIC, INC.
Model
37704
Device description
INS 37704 ITREL 4X NEUROSTIMULATOR
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
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840001211

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840001211ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169107809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169107809006431691078096431691078090643169107809

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation systemAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius52 Degrees Celsius
Handling Environment Temperature0 Degrees Fahrenheit126 Degrees Fahrenheit

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09352307001756Evoke® CAP24 Paddle Lead KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001787Evoke® CAP24 Paddle Accessory KitSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
00763000520083N/AMEDTRONIC, INC.LGW2021-07-23
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729970606Bionic Navigator™ 3DBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-01-16
08714729953463Patient Trial KitBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-06-05
08714729935070NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935124NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935179NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935186NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729937395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935056NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729935063NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2017-04-14
08714729931492NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-05-03
08714729763352Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-02-23
08714729789697Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729789703Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2016-01-05
08714729767534Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767541Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729767558Precision™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779957NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729779964NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789567Linear™ 3-6BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729789581Linear™ 3-4BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797807Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14
08714729797814Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2015-12-14