FDA.reportPublic FDA data

NA

Primary DI
05414734401500
Brand
NA
Company
ADVANCED NEUROMODULATION SYSTEMS, INC.
Model
3009
Catalog number
3009
Device description
Trial Cable
Published
2015-04-25
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
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
K033757000
K070847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033757000MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEMAdvanced Neuromodulation Systems2004-01-30GZB
K070847000TRIAL CABLE, 3009Advanced Neuromodulation Systems2007-04-11GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734401507PackageGS12In Commercial Distribution
05414734401500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473440150715414734401507
05414734401500054147344015005414734401500

GMDN Terms#

Term, Definition table
TermDefinition
Pin-indexed adaptor, reusableA connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Special Storage Condition, Specify00KEEP DRY
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
021675699
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054111N/A121012102026-03-02
05415067055880Proclaim™788478842026-02-13
05415067055842Proclaim™388438842026-02-13
05415067055866Infinity™688468842026-02-13
05415067053060NAMN13650MN136502025-12-07
05415067051899NA66700667002025-01-24
05415067051905NA36700367002025-01-24
05415067047670NA66000660002024-02-16
05415067045652NA16750167502023-01-04
05415067045676NA16760167602023-01-04
05414734400107NA111211122014-11-12
05414734400176NA112011202014-10-23
05415067023971Proclaim™388438842016-03-31
05415067051882NA304230422025-04-09
05415067050311NeuroSphere™387638762025-01-17
05415067045713NA12710127102023-01-04
05414734400961MTS™127312732014-10-22
05414734401548Quattrode™306630662015-04-25
05415067027313Proclaim™788478842017-03-23
05415067029072NA788578852017-11-16

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Primary DI, Brand, Company table
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00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30
00812537034355Nalu Medical, Inc.NALU MEDICAL, INC.GZB2022-09-30
00812537033822Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-10-12
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
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10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
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00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
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00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030203Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030210Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21