ALAR®

GUDID 20763000038186

STENT 15000 2PK ALAR NASALVALVE COLLAPSE

MEDTRONIC XOMED, INC.

Intranasal splinting set

• Primary Device ID: 20763000038186
• NIH Device Record Key: c508b80a-48d7-46fa-b5ea-fc8cbea98e36
• 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: false
• 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

Device Dimensions

• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter
• Height: 0.5 Millimeter
• Width: 16 Millimeter
• Length: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000038182 [Primary]
GS1	20763000038186 [Package]; Contains: 00763000038182; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [ALAR®]

• 20643169700899: STENT 15000 2PK ALAR NASALVALVE COLLAPSE
• 20763000038186: STENT 15000 2PK ALAR NASALVALVE COLLAPSE