Freezor® MAX

GUDID 00643169450387

CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F

MEDTRONIC, INC.

Cardiac cryosurgical system catheter Cardiac cryosurgical system catheter
Primary Device ID00643169450387
NIH Device Record Keyff9919b4-c70b-4539-b5e4-3853631051ed
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFreezor® MAX
Version Model Number239F5
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

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169450387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-10
Device Publish Date2014-12-01

On-Brand Devices [Freezor® MAX]

00613994804273CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169023505CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
00643169023499CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
00643169023482CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169023475CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
00643169504929CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
00643169504912CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
00643169504905CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169504899CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
00643169450387CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
00643169450370CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00643169450363CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F
00643169450356CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F
00763000245474CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
00763000245481CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F

Trademark Results [Freezor]

Mark Image

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

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