Axium™ MN14000

GUDID 05415067025708

Curved Needle

SPINAL MODULATION, INC.

Epidural needle, non-threaded
Primary Device ID05415067025708
NIH Device Record Keyf1681c16-8467-43e1-8beb-a2ceb1cac926
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxium™
Version Model NumberMN14000
Catalog NumberMN14000
Company DUNS617312272
Company NameSPINAL MODULATION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Needle Gauge14 Gauge
Length4.5 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067025708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMPDorsal root ganglion stimulator for pain relief

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-29

On-Brand Devices [Axium™]

05415067027344Lead Accessories Kit
0541506702733750cm SlimTip™ Implant Lead Kit
05415067025708Curved Needle
05415067025678Lead Accessories Kit
0541506702561622cm Big Curve Delivery Sheath Kit
0541506702560922cm Small Curve Delivery Sheath Kit
0541506702556250cm Lead Extension Kit
05415067025555Connector Cable Kit
0541506702554890cm SlimTip™ Implant Lead Kit
0541506702553150cm SlimTip™ Implant Lead Kit
0541506702552490cm SlimTip™ Trial Lead Kit
0541506702551750cm SlimTip™ Trial Lead Kit

Trademark Results [Axium]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AXIUM
AXIUM
97769154 not registered Live/Pending
Axium Solutions ULC
2023-01-26
AXIUM
AXIUM
97763019 not registered Live/Pending
Year33 Inc.
2023-01-20
AXIUM
AXIUM
90596375 not registered Live/Pending
Vadovations, Inc.
2021-03-23
AXIUM
AXIUM
88381237 not registered Live/Pending
KINETICO INCORPORATED
2019-04-11
AXIUM
AXIUM
87338441 not registered Dead/Abandoned
L18 Holdings, Inc.
2017-02-16
AXIUM
AXIUM
85872397 not registered Dead/Abandoned
Automatic Equipment Manufacturing Company
2013-03-11
AXIUM
AXIUM
85463170 4564567 Live/Registered
Spinal Modulation, Inc.
2011-11-03
AXIUM
AXIUM
85194906 3997317 Dead/Cancelled
Master Brands HK Limited
2010-12-10
AXIUM
AXIUM
85194877 3997315 Dead/Cancelled
Master Brands HK Limited
2010-12-10
AXIUM
AXIUM
79243756 not registered Live/Pending
INGENICO GROUP
2018-07-09
AXIUM
AXIUM
78761181 not registered Dead/Abandoned
Axium Management, Inc.
2005-11-27
AXIUM
AXIUM
78748165 3540355 Live/Registered
Axium Consulting LLC
2005-11-07

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