Exclaim™ 3225

GUDID 05415067017758

ST. JUDE MEDICAL, INC.

Analgesic spinal cord electrical stimulation system
Primary Device ID05415067017758
NIH Device Record Keybabd685b-e8a6-4ab4-92e4-f8644e9b1c25
Commercial Distribution StatusIn Commercial Distribution
Brand NameExclaim™
Version Model Number3225
Catalog Number3225
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter
Length90 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Handling Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067017758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number2
Public Version Date2018-03-29
Device Publish Date2015-03-17

On-Brand Devices [Exclaim™]

054150670177583225
054147344061783224
054147344018833225

Trademark Results [Exclaim]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCLAIM
EXCLAIM
98134001 not registered Live/Pending
SIGMAWEAR, LLC
2023-08-15
EXCLAIM
EXCLAIM
87900377 not registered Live/Pending
edjuster Inc.
2018-04-30
EXCLAIM
EXCLAIM
85852320 not registered Dead/Abandoned
Exclaim Design Inc
2013-02-18
EXCLAIM
EXCLAIM
85799920 4468949 Live/Registered
Continental Tire The Americas, LLC
2012-12-11
EXCLAIM
EXCLAIM
78902832 not registered Dead/Abandoned
dotPhoto, Inc. DBA Exclaim
2006-06-07
EXCLAIM
EXCLAIM
78857513 3416038 Dead/Cancelled
STAPLES, INC.
2006-04-10
EXCLAIM
EXCLAIM
78621282 not registered Dead/Abandoned
PFS NEW MEDIA, INC. d/b/a PFS MARKETWYSE
2005-05-02
EXCLAIM
EXCLAIM
78314331 2947785 Dead/Cancelled
HMR Pharma, Inc.
2003-10-16
EXCLAIM
EXCLAIM
78195848 not registered Dead/Abandoned
Scimed Life Systems, Inc.
2002-12-18
EXCLAIM
EXCLAIM
78097882 2745132 Dead/Cancelled
AVENTISUB II INC.
2001-12-12
EXCLAIM
EXCLAIM
78086029 not registered Dead/Abandoned
Pharmacia & Upjohn Company
2001-09-28
EXCLAIM
EXCLAIM
77914955 4056910 Dead/Cancelled
AVENTISUB LLC
2010-01-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.