Fortrex™

GUDID 00763000634957

PTA A35HPV12080135 FORTREX V04

MEDTRONIC, INC.

Peripheral angioplasty balloon catheter, basic
Primary Device ID00763000634957
NIH Device Record Key80065d26-5b05-4171-9d32-e2a731046871
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortrex™
Version Model NumberA35HPV12080135
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
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
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
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

Device Dimensions

Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter
Length135 Centimeter
Device Size Text, specify0
Catheter Gauge7 French
Outer Diameter12 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
Special Storage Condition, SpecifyBetween 0 and 0 *Rotate inventory so that the device is used before the Use-by date on the package label.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000634957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-23
Device Publish Date2024-02-15

On-Brand Devices [Fortrex™]

00763000634957PTA A35HPV12080135 FORTREX V04
00763000634940PTA A35HPV12080080 FORTREX V04
00763000634933PTA A35HPV12080040 FORTREX V04
00763000634926PTA A35HPV12040135 FORTREX V04
00763000634919PTA A35HPV12040080 FORTREX V04
00763000634902PTA A35HPV12040040 FORTREX V04
00763000634896PTA A35HPV10080135 FORTREX V04
00763000634889PTA A35HPV10080080 FORTREX V04
00763000634872PTA A35HPV10080040 FORTREX V04
00763000634865PTA A35HPV10040135 FORTREX V04
00763000634858PTA A35HPV10040080 FORTREX V04
00763000634841PTA A35HPV10040040 FORTREX V04
00763000634834PTA A35HPV09080135 FORTREX V04
00763000634827PTA A35HPV09080080 FORTREX V04
00763000634810PTA A35HPV09080040 FORTREX V04
00763000634803PTA A35HPV09040135 FORTREX V04
00763000634797PTA A35HPV09040080 FORTREX V04
00763000634780PTA A35HPV09040040 FORTREX V04
00763000634773PTA A35HPV08100135 FORTREX V04
00763000634766PTA A35HPV08100080 FORTREX V04
00763000634759PTA A35HPV08100040 FORTREX V04
00763000634742PTA A35HPV08080135 FORTREX V04
00763000634735PTA A35HPV08080080 FORTREX V04
00763000634728PTA A35HPV08080040 FORTREX V04
00763000634711PTA A35HPV08040135 FORTREX V04
00763000634704PTA A35HPV08040080 FORTREX V04
00763000634698PTA A35HPV08040040 FORTREX V04
00763000634681PTA A35HPV07100135 FORTREX V04
00763000634674PTA A35HPV07100080 FORTREX V04
00763000634667PTA A35HPV07100040 FORTREX V04
00763000634650PTA A35HPV07080135 FORTREX V04
00763000634643PTA A35HPV07080080 FORTREX V04
00763000634636PTA A35HPV07080040 FORTREX V04
00763000634629PTA A35HPV07040135 FORTREX V04
00763000634612PTA A35HPV07040080 FORTREX V04
00763000634605PTA A35HPV07040040 FORTREX V04
00763000634599PTA A35HPV07020135 FORTREX V04
00763000634582PTA A35HPV07020080 FORTREX V04
00763000634575PTA A35HPV07020040 FORTREX V04
00763000634568PTA A35HPV06100135 FORTREX V04
00763000634551PTA A35HPV06100080 FORTREX V04
00763000634544PTA A35HPV06100040 FORTREX V04
00763000634537PTA A35HPV06080135 FORTREX V04
00763000634520PTA A35HPV06080080 FORTREX V04
00763000634513PTA A35HPV06080040 FORTREX V04
00763000634506PTA A35HPV06040135 FORTREX V04
00763000634490PTA A35HPV06040080 FORTREX V04
00763000634483PTA A35HPV06040040 FORTREX V04
00763000634476PTA A35HPV06020135 FORTREX V04
00763000634469PTA A35HPV06020080 FORTREX V04

Trademark Results [Fortrex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FORTREX
FORTREX
97438582 not registered Live/Pending
Kent Nutrition Group, Inc.
2022-06-01
FORTREX
FORTREX
97010416 not registered Live/Pending
Cooper-Standard Automotive Inc.
2021-09-03
FORTREX
FORTREX
88170628 not registered Live/Pending
Schweitzer-Mauduit International, Inc.
2018-10-26
FORTREX
FORTREX
88144654 not registered Live/Pending
Cooper-Standard Automotive Inc.
2018-10-05
FORTREX
FORTREX
88093815 not registered Live/Pending
Cooper-Standard Automotive Inc.
2018-08-27
FORTREX
FORTREX
86983024 5307518 Live/Registered
Cooper-Standard Automotive Inc.
2014-07-21
FORTREX
FORTREX
86387647 4928336 Live/Registered
Covidien LP
2014-09-08
FORTREX
FORTREX
86343246 not registered Dead/Abandoned
Cooper-Standard Automotive Inc.
2014-07-21
FORTREX
FORTREX
85957797 4432639 Live/Registered
DRIFIRE, LLC
2013-06-12
FORTREX
FORTREX
77347860 3544770 Live/Registered
Johnson Outdoors Inc.
2007-12-10
FORTREX
FORTREX
76089077 not registered Dead/Abandoned
Perez, Alain
2000-07-14
FORTREX
FORTREX
75821545 2421050 Live/Registered
FORTREX, LLC
1999-10-12
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.