Axium™

Primary DI
05415067025616
Brand
Axium™
Company
SPINAL MODULATION, INC.
Model
MN13650
Catalog number
MN13650
Device description
22cm Big Curve Delivery Sheath Kit
Published
2016-03-29
Public version status
Update
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
P150004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150004000Axium Neurostimulator SystemABBOTT MEDICAL2016-02-11PMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067025616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067025616054150670256165415067025616

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
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry. Do not use if package is damaged.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
617312272
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067025562Axium™MN10550-50MN10550-502016-03-29
05415067025517Axium™MN10350-50AMN10350-50A2016-03-29
05415067025524Axium™MN10350-90AMN10350-90A2016-03-29
05415067025531Axium™MN10450-50AMN10450-50A2016-03-29
05415067025548Axium™MN10450-90AMN10450-90A2016-03-29
05415067025555Axium™MN11350MN113502016-03-29
05415067025609Axium™MN12150MN121502016-03-29
05415067025678Axium™MN12050MN120502016-03-29
05415067025708Axium™MN14000MN140002016-03-29
05415067027337Axium™MN10450-50AMN10450-50A2017-05-24
05415067027344Axium™MN12050MN120502017-05-24

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
05415067053060NAADVANCED NEUROMODULATION SYSTEMS, INC.PMP2025-12-07
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