Resolute Onyx™

GUDID 00643169602694

STENT RONYX40018W RESOLUTE ONYX 4.00X18

MEDTRONIC, INC.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Primary Device ID00643169602694
NIH Device Record Key0970d868-1f1b-48ae-a524-977752b6ec58
Commercial Distribution StatusIn Commercial Distribution
Brand NameResolute Onyx™
Version Model NumberRONYX40018W
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
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

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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 the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169602694 [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 Date2017-05-11

On-Brand Devices [Resolute Onyx™]

00643169602748STENT RONYX40038W RESOLUTE ONYX 4.00X38
00643169602731STENT RONYX40034W RESOLUTE ONYX 4.00X34
00643169602724STENT RONYX40030W RESOLUTE ONYX 4.00X30
00643169602717STENT RONYX40026W RESOLUTE ONYX 4.00X26
00643169602700STENT RONYX40022W RESOLUTE ONYX 4.00X22
00643169602694STENT RONYX40018W RESOLUTE ONYX 4.00X18
00643169602687STENT RONYX40015W RESOLUTE ONYX 4.00X15
00643169602670STENT RONYX40012W RESOLUTE ONYX 4.00X12
00643169602663STENT RONYX40008W RESOLUTE ONYX 4.00X08
00643169602656STENT RONYX35038W RESOLUTE ONYX 3.50X38
00643169602649STENT RONYX35034W RESOLUTE ONYX 3.50X34
00643169602632STENT RONYX35030W RESOLUTE ONYX 3.50X30
00643169602625STENT RONYX35026W RESOLUTE ONYX 3.50X26
00643169602618STENT RONYX35022W RESOLUTE ONYX 3.50X22
00643169602601STENT RONYX35018W RESOLUTE ONYX 3.50X18
00643169602595STENT RONYX35015W RESOLUTE ONYX 3.50X15
00643169602588STENT RONYX35012W RESOLUTE ONYX 3.50X12
00643169602571STENT RONYX35008W RESOLUTE ONYX 3.50X08
00643169602564STENT RONYX30038W RESOLUTE ONYX 3.00X38
00643169602557STENT RONYX30034W RESOLUTE ONYX 3.00X34
00643169602540STENT RONYX30030W RESOLUTE ONYX 3.00X30
00643169602533STENT RONYX30026W RESOLUTE ONYX 3.00X26
00643169602526STENT RONYX30022W RESOLUTE ONYX 3.00X22
00643169602519STENT RONYX30018W RESOLUTE ONYX 3.00X18
00643169602502STENT RONYX30015W RESOLUTE ONYX 3.00X15
00643169602496STENT RONYX30012W RESOLUTE ONYX 3.00X12
00643169602489STENT RONYX30008W RESOLUTE ONYX 3.00X08
00643169602472STENT RONYX27538W RESOLUTE ONYX 2.75X38
00643169602465STENT RONYX27534W RESOLUTE ONYX 2.75X34
00643169602458STENT RONYX27530W RESOLUTE ONYX 2.75X30
00643169602441STENT RONYX27526W RESOLUTE ONYX 2.75X26
00643169602434STENT RONYX27522W RESOLUTE ONYX 2.75X22
00643169602427STENT RONYX27518W RESOLUTE ONYX 2.75X18
00643169602410STENT RONYX27515W RESOLUTE ONYX 2.75X15
00643169602403STENT RONYX27512W RESOLUTE ONYX 2.75X12
00643169602397STENT RONYX27508W RESOLUTE ONYX 2.75X08
00643169602380STENT RONYX25038W RESOLUTE ONYX 2.50X38
00643169602373STENT RONYX25034W RESOLUTE ONYX 2.50X34
00643169602366STENT RONYX25030W RESOLUTE ONYX 2.50X30
00643169602359STENT RONYX25026W RESOLUTE ONYX 2.50X26
00643169602342STENT RONYX25022W RESOLUTE ONYX 2.50X22
00643169602335STENT RONYX25018W RESOLUTE ONYX 2.50X18
00643169602328STENT RONYX25015W RESOLUTE ONYX 2.50X15
00643169602311STENT RONYX25012W RESOLUTE ONYX 2.50X12
00643169602304STENT RONYX25008W RESOLUTE ONYX 2.50X08
00643169602298STENT RONYX22538W RESOLUTE ONYX 2.25X38
00643169602281STENT RONYX22534W RESOLUTE ONYX 2.25X34
00643169602274STENT RONYX22530W RESOLUTE ONYX 2.25X30
00643169602267STENT RONYX22526W RESOLUTE ONYX 2.25X26
00643169602250STENT RONYX22522W RESOLUTE ONYX 2.25X22

Trademark Results [Resolute Onyx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESOLUTE ONYX
RESOLUTE ONYX
86098251 5228405 Live/Registered
Medtronic Vascular, Inc.
2013-10-22

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