RF-DGP-IZ

GUDID 05415067049650

Grounding Pad

ST. JUDE MEDICAL, INC.

Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use

Primary Device ID	05415067049650
NIH Device Record Key	f3c33ca5-8cb7-4d54-97bb-a531e0b4eb73
Commercial Distribution Status	In Commercial Distribution
Version Model Number	RF-DGP-IZ
Catalog Number	RF-DGP-IZ
Company DUNS	149818952
Company Name	ST. JUDE MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Excursions permitted: -5C-40C (23F-104F)
Storage Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 21 Degrees Celsius and 25 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067049650 [Primary]
GS1	15415067049657 [Package] Package: [25 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K203293

FDA Product Code

GXD	Generator, lesion, radiofrequency

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-03
Device Publish Date	2024-03-26

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