Alar ™

GUDID 20643169232000

STENT 15000 2PK ALAR NASALVALVE COLLAPSE

MEDTRONIC XOMED, INC.

Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set Intranasal splinting set

• Primary Device ID: 20643169232000
• NIH Device Record Key: 7ac3ff95-dcac-4f84-943f-e6efabd87969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alar ™
• Version Model Number: 15000
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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

Device Dimensions

• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Width: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169232006 [Primary]
GS1	20643169232000 [Package]; Contains: 00643169232006; Package: PK [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151758

FDA Product Code

• LYA: SPLINT, INTRANASAL SEPTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-13

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