Resolute Integrity™

GUDID 00643169037212

Stent RSINT40018UX MicroTrac 4.00X18RX

MEDTRONIC, INC.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

Primary Device ID	00643169037212
NIH Device Record Key	1dbbe650-592a-4b9d-bfc0-60837526cc92
Commercial Distribution Status	In Commercial Distribution
Brand Name	Resolute Integrity™
Version Model Number	RSINT40018UX
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter
Device Size Text, specify	0
Length	18 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in original container.
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169037212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P110013

FDA Product Code

NIQ	Coronary drug-eluting stent

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-09-23

On-Brand Devices [Resolute Integrity™]

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