Resolute Integrity™

GUDID 00643169037304

Stent RSINT40009UX MicroTrac 4.00X9RX

MEDTRONIC, INC.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Primary Device ID00643169037304
NIH Device Record Key707f296e-08ad-476b-b2a6-bf34d85134a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameResolute Integrity™
Version Model NumberRSINT40009UX
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
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

Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
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Length9 Millimeter
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Length9 Millimeter
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Length9 Millimeter
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Length9 Millimeter
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Length9 Millimeter
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Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
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Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter
Device Size Text, specify0
Length9 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in original container.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169037304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIQCoronary drug-eluting stent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [Resolute Integrity™]

00613994793508Stent RSINT27508W MicroTrac 2.75X8OTW
00613994793492Stent RSINT27512W MicroTrac 2.75X12OTW
00613994793485Stent RSINT27514W MicroTrac 2.75X14OTW
00613994793478Stent RSINT27518W MicroTrac 2.75X18OTW
00613994793461Stent RSINT27522W MicroTrac 2.75X22OTW
00613994793454Stent RSINT27526W MicroTrac 2.75X26OTW
00613994793447Stent RSINT27530W MicroTrac 2.75X30OTW
00613994793430Stent RSINT30009W MicroTrac 3.00X9OTW
00613994793423Stent RSINT30012W MicroTrac 3.00X12OTW
00613994793416Stent RSINT30015W MicroTrac 3.00X15OTW
00613994793409Stent RSINT30018W MicroTrac 3.00X18OTW
00613994793393Stent RSINT30022W MicroTrac 3.00X22OTW
00613994793386Stent RSINT22508W MicroTrac 2.25X8OTW
00613994793379Stent RSINT22518W MicroTrac 2.25X18OTW
00613994793362Stent RSINT22522W MicroTrac 2.25X22OTW
00613994793355Stent RSINT22526W MicroTrac 2.25X26OTW
00613994793348Stent RSINT22530W MicroTrac 2.25X30OTW
00613994793331Stent RSINT25008W MicroTrac 2.50X8OTW
00613994793324Stent RSINT25012W MicroTrac 2.50X12OTW
00613994793317Stent RSINT25014W MicroTrac 2.50X14OTW
00613994793300Stent RSINT25018W MicroTrac 2.50X18OTW
00613994793294Stent RSINT25022W MicroTrac 2.50X22OTW
00613994793287Stent RSINT25026W MicroTrac 2.50X26OTW
00613994793270Stent RSINT25030W MicroTrac 2.50X30OTW
00613994793263Stent RSINT35038W MicroTrac 3.50X38OTW
00613994793256Stent RSINT40009W MicroTrac 4.00X9OTW
00613994793249Stent RSINT22512W MicroTrac 2.25X12OTW
00613994793232Stent RSINT22514W MicroTrac 2.25X14OTW
00613994793225Stent RSINT40012W MicroTrac 4.00X12OTW
00613994793218Stent RSINT40015W MicroTrac 4.00X15OTW
00613994793201Stent RSINT40018W MicroTrac 4.00X18OTW
00613994793195Stent RSINT40022W MicroTrac 4.00X22OTW
00613994793188Stent RSINT40026W MicroTrac 4.00X26OTW
00613994793171Stent RSINT40030W MicroTrac 4.00X30OTW
00613994793164Stent RSINT40034W MicroTrac 4.00X34OTW
00613994793157Stent RSINT40038W MicroTrac 4.00X38OTW
00613994793140Stent RSINT30026W MicroTrac 3.00X26OTW
00613994793133Stent RSINT30030W MicroTrac 3.00X30OTW
00613994793126Stent RSINT30034W MicroTrac 3.00X34OTW
00613994793119Stent RSINT30038W MicroTrac 3.00X38OTW
00613994793102Stent RSINT35009W MicroTrac 3.50X9OTW
00613994793096Stent RSINT35012W MicroTrac 3.50X12OTW
00613994793089Stent RSINT35015W MicroTrac 3.50X15OTW
00613994793072Stent RSINT35018W MicroTrac 3.50X18OTW
00613994793065Stent RSINT35022W MicroTrac 3.50X22OTW
00613994793058Stent RSINT35026W MicroTrac 3.50X26OTW
00613994793041Stent RSINT35030W MicroTrac 3.50X30OTW
00613994793034Stent RSINT35034W MicroTrac 3.50X34OTW
00643169037564Stent RSINT27518UX MicroTrac 2.75X18RX
00643169037557Stent RSINT27514UX MicroTrac 2.75X14RX
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