NA

Primary DI
05415067053060
Brand
NA
Company
ADVANCED NEUROMODULATION SYSTEMS, INC.
Model
MN13650
Catalog number
MN13650
Device description
DRG Big Curve Delivery Sheath Kit
Published
2025-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMPDorsal root ganglion stimulator for pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMPDorsal Root Ganglion Stimulator For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150004074

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150004074Axium Neurostimulator SystemABBOTT MEDICAL2016-02-11PMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067053060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067053060054150670530605415067053060

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length22Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Special Storage Condition, Specify00Store at room temperature 23C/73F. Excursions allowed between -20C to 60C
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
021675699
Device count
1
Serial number
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
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
05414734401500NA300930092015-04-25
05414734400961MTS™127312732014-10-22
05414734401548Quattrode™306630662015-04-25
05415067027313Proclaim™788478842017-03-23
05415067029072NA788578852017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067054111N/AADVANCED NEUROMODULATION SYSTEMS, INC.PMP2026-03-02
05415067055880Proclaim™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2026-02-13
05415067050311NeuroSphere™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2025-01-17
05415067046956NeuroSphere™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046376Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046383Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046390Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046406Proclaim™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067046970NeuroSphere™ST. JUDE MEDICAL, INC.PMP2022-09-01
05415067027122NAST. JUDE MEDICAL, INC.PMP2017-11-16
05415067027863NAST. JUDE MEDICAL, INC.PMP2017-11-16
05415067029072NAADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-11-16
05415067027238SJM™ST. JUDE MEDICAL, INC.PMP2017-07-24
05415067027139SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027146SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027153SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027160SlimTip™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-07-21
05415067027177NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027191NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027207NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027214NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027221NAST. JUDE MEDICAL, INC.PMP2017-07-21
05415067027184NAST. JUDE MEDICAL, INC.PMP2017-05-24
05415067027337Axium™SPINAL MODULATION, INC.PMP2017-05-24
05415067027344Axium™SPINAL MODULATION, INC.PMP2017-05-24
05415067026996NAST. JUDE MEDICAL, INC.PMP2017-03-23
05415067020215Proclaim™ST. JUDE MEDICAL, INC.PMP2017-03-23
15415067026993NAST. JUDE MEDICAL, INC.PMP2017-03-23
05415067027313Proclaim™ADVANCED NEUROMODULATION SYSTEMS, INC.PMP2017-03-23
05415067025494Axium™ST. JUDE MEDICAL, INC.PMP2016-03-29