ClosureRFG™

GUDID 10884521777545

GENERATOR RFG3 CLOSUREFAST

MEDTRONIC, INC.

Percutaneous radio-frequency ablation system generator
Primary Device ID10884521777545
NIH Device Record Keycad5e9c1-df29-4033-9036-3477f42faa16
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosureRFG™
Version Model NumberRFG3
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, SpecifyBetween 0 and 0 *500 - 1060 hPa
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, SpecifyBetween 0 and 0 *500 - 1060 hPa
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, SpecifyBetween 0 and 0 *500 - 1060 hPa
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, SpecifyBetween 0 and 0 *500 - 1060 hPa
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, SpecifyBetween 0 and 0 *500 - 1060 hPa
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Relative humidity (non-condensing) between 10% and 90% for temperatures between -20° C and 40° C (-4°F and 104°F), and between 10% and 60% for temperatures between 40° C and 70° C (104°F and 158°F).
Special Storage Condition, SpecifyBetween 0 and 0 *500 - 1060 hPa
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521777545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2019-08-10

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