Onyx Frontier™

GUDID 00763000511616

STENT ONYXNG35034UX ONYX 3.50X34RX

MEDTRONIC, INC.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Primary Device ID00763000511616
NIH Device Record Keybb89a00d-1eff-4a8d-aedb-88abdb88e97c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnyx Frontier™
Version Model NumberONYXNG35034UX
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

Device Dimensions

Stent Diameter3.5 Millimeter
Stent Length34 Millimeter
Stent Diameter3.5 Millimeter
Stent Length34 Millimeter
Stent Diameter3.5 Millimeter
Stent Length34 Millimeter
Stent Diameter3.5 Millimeter
Stent Length34 Millimeter
Stent Diameter3.5 Millimeter
Stent Length34 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000511616 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-11

On-Brand Devices [Onyx Frontier™]

00763000511838STENT ONYXNG50030UX ONYX 5.00X30RX
00763000511821STENT ONYXNG50026UX ONYX 5.00X26RX
00763000511814STENT ONYXNG50022UX ONYX 5.00X22RX
00763000511807STENT ONYXNG50018UX ONYX 5.00X18RX
00763000511791STENT ONYXNG50015UX ONYX 5.00X15RX
00763000511784STENT ONYXNG50012UX ONYX 5.00X12RX
00763000511777STENT ONYXNG45030UX ONYX 4.50X30RX
00763000511760STENT ONYXNG45026UX ONYX 4.50X26RX
00763000511753STENT ONYXNG45022UX ONYX 4.50X22RX
00763000511746STENT ONYXNG45018UX ONYX 4.50X18RX
00763000511739STENT ONYXNG45015UX ONYX 4.50X15RX
00763000511722STENT ONYXNG45012UX ONYX 4.50X12RX
00763000511715STENT ONYXNG40038UX ONYX 4.00X38RX
00763000511708STENT ONYXNG40034UX ONYX 4.00X34RX
00763000511692STENT ONYXNG40030UX ONYX 4.00X30RX
00763000511685STENT ONYXNG40026UX ONYX 4.00X26RX
00763000511678STENT ONYXNG40022UX ONYX 4.00X22RX
00763000511661STENT ONYXNG40018UX ONYX 4.00X18RX
00763000511654STENT ONYXNG40015UX ONYX 4.00X15RX
00763000511647STENT ONYXNG40012UX ONYX 4.00X12RX
00763000511630STENT ONYXNG40008UX ONYX 4.00X08RX
00763000511623STENT ONYXNG35038UX ONYX 3.50X38RX
00763000511616STENT ONYXNG35034UX ONYX 3.50X34RX
00763000511609STENT ONYXNG35030UX ONYX 3.50X30RX
00763000511593STENT ONYXNG35026UX ONYX 3.50X26RX
00763000511586STENT ONYXNG35022UX ONYX 3.50X22RX
00763000511579STENT ONYXNG35018UX ONYX 3.50X18RX
00763000511562STENT ONYXNG35015UX ONYX 3.50X15RX
00763000511555STENT ONYXNG35012UX ONYX 3.50X12RX
00763000511548STENT ONYXNG35008UX ONYX 3.50X08RX
00763000511531STENT ONYXNG30038UX ONYX 3.00X38RX
00763000511524STENT ONYXNG30034UX ONYX 3.00X34RX
00763000511517STENT ONYXNG30030UX ONYX 3.00X30RX
00763000511500STENT ONYXNG30026UX ONYX 3.00X26RX
00763000511494STENT ONYXNG30022UX ONYX 3.00X22RX
00763000511487STENT ONYXNG30018UX ONYX 3.00X18RX
00763000511470STENT ONYXNG30015UX ONYX 3.00X15RX
00763000511463STENT ONYXNG30012UX ONYX 3.00X12RX
00763000511456STENT ONYXNG30008UX ONYX 3.00X08RX
00763000511449STENT ONYXNG27538UX ONYX 2.75X38RX
00763000511432STENT ONYXNG27534UX ONYX 2.75X34RX
00763000511425STENT ONYXNG27530UX ONYX 2.75X30RX
00763000511395STENT ONYXNG27518UX ONYX 2.75X18RX
00763000511388STENT ONYXNG27515UX ONYX 2.75X15RX
00763000511371STENT ONYXNG27512UX ONYX 2.75X12RX
00763000511364STENT ONYXNG27508UX ONYX 2.75X08RX
00763000511357STENT ONYXNG25038UX ONYX 2.50X38RX
00763000511340STENT ONYXNG25034UX ONYX 2.50X34RX
00763000511333STENT ONYXNG25030UX ONYX 2.50X30RX
00763000511326STENT ONYXNG25026UX ONYX 2.50X26RX

Trademark Results [Onyx Frontier]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONYX FRONTIER
ONYX FRONTIER
90367714 not registered Live/Pending
Medtronic, Inc
2020-12-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.