SJM™ 1115

GUDID 15414734400135

Epidural Needle, 15 gauge, 4" (10cm)

ADVANCED NEUROMODULATION SYSTEMS, INC.

Epidural needle, non-threaded
Primary Device ID15414734400135
NIH Device Record Key69570536-6023-4229-b703-ab6911a5c126
Commercial Distribution Discontinuation2018-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSJM™
Version Model Number1115
Catalog Number1115
Company DUNS021675699
Company NameADVANCED NEUROMODULATION SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Gauge15 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734400138 [Primary]
GS115414734400135 [Package]
Contains: 05414734400138
Package: [5 Units]
Discontinued: 2018-03-28
Not in Commercial Distribution

FDA Product Code

LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-04-30
Device Publish Date2014-10-23

On-Brand Devices [SJM™]

05415067023810Patient Controller App
05415067023803Clinician Programmer App
054147344024773701
054147344010051291
054147344009851280
05414734400794Communication Wand
054147344007631210
154147344001731120
15414734400135Epidural Needle, 15 gauge, 4" (10cm)
154147344001041112
154147344000121101

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