N/A RF-DGP-IS

GUDID 15415067034516

Grounding Pad

ST. JUDE MEDICAL, INC.

Electrosurgical return electrode, single-use
Primary Device ID15415067034516
NIH Device Record Key0c0736b7-0052-4faf-81fb-2df880e4bacc
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberRF-DGP-IS
Catalog NumberRF-DGP-IS
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 Datefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067034519 [Primary]
GS115415067034516 [Package]
Contains: 05415067034519
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXDGenerator, lesion, radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

On-Brand Devices [N/A]

05415067001825Power Cord
05415067037572Monitor Cable
15415067034516Grounding Pad

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