Onyx Frontier™

GUDID 00763000511616

STENT ONYXNG35034UX ONYX 3.50X34RX

MEDTRONIC, INC.

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

• Primary Device ID: 00763000511616
• NIH Device Record Key: bb89a00d-1eff-4a8d-aedb-88abdb88e97c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onyx Frontier™
• Version Model Number: ONYXNG35034UX
• 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

Device Dimensions

• Stent Diameter: 3.5 Millimeter
• Stent Length: 34 Millimeter
• Stent Diameter: 3.5 Millimeter
• Stent Length: 34 Millimeter
• Stent Diameter: 3.5 Millimeter
• Stent Length: 34 Millimeter
• Stent Diameter: 3.5 Millimeter
• Stent Length: 34 Millimeter
• Stent Diameter: 3.5 Millimeter
• Stent Length: 34 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000511616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160043

FDA Product Code

• NIQ: Coronary drug-eluting stent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-11

On-Brand Devices [Onyx Frontier™]

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