Freezor® Xtra

GUDID 00643169023512

CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter
Primary Device ID00643169023512
NIH Device Record Keyf34f2844-fb0a-45a8-85e1-25b0649951f0
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFreezor® Xtra
Version Model Number227F5
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169023512 [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 [Freezor® Xtra]

00613994610829CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
00613994610812CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
00613994610805CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
00643169023536CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
00643169023529CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
00643169023512CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
00643169672482CATHETER 227F5 FREEZOR XTRA5 LG 7F
00643169672475CATHETER 227F3 FREEZOR XTRA3 MED7F
00643169672468CATHETER 227F1 FREEZOR XTRA1 SH 7F
00643169504950CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F
00643169504943CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
00643169504936CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
00643169450349CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F
00643169450332CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
00643169450325CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F

Trademark Results [Freezor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREEZOR
FREEZOR
75664372 2498756 Live/Registered
MEDTRONIC CRYOCATH LP
1999-03-19

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