RF ENHANCR® II

GUDID 00643169147942

CATH 31745533 RF ENHANCR II W/O CE

MEDTRONIC, INC.

Cardiac radio-frequency ablation system catheter
Primary Device ID00643169147942
NIH Device Record Key8f01cfcd-9e41-4275-bb8b-438873137b88
Commercial Distribution StatusIn Commercial Distribution
Brand NameRF ENHANCR® II
Version Model Number31745533
Company DUNS006261481
Company NameMEDTRONIC, 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 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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169147942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [RF ENHANCR® II]

00643169147980CATH 39746534 RF ENHANCR II W/O CE
00643169147966CATH 39745533 RF ENHANCR II W/O CE
00643169147942CATH 31745533 RF ENHANCR II W/O CE
00643169147928CATH 31745523 RF ENHANCR II W/O CE
00643169147904CATH 31744523 RF ENHANCR II W/O CE

Trademark Results [RF ENHANCR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RF ENHANCR
RF ENHANCR
78057650 2698775 Live/Registered
MEDTRONIC INC.
2001-04-10

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