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Alar®

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
ALAR® FDA UDI
Generic Name
Intranasal splinting set FDA UDI
Device Name
STENT 15000 2PK ALAR NASALVALVE COLLAPSE FDA UDI
Model / Reference
15000 FDA UDI
Description
STENT 15000 2PK ALAR NASALVALVE COLLAPSE FDA UDI

Identifiers

Primary DI / UDI-DI
00763000038182 FDA UDI
510(k) Number
K151758 FDA UDI
FDA Product Code
LYA FDA UDI
GMDN Term
Intranasal splinting set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 0.5 Millimeter FDA UDI
Width — 16.0 Millimeter FDA UDI
Length — 19.0 Millimeter FDA UDI

Category: Intranasal splinting set

Alar® by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intranasal splinting set.

Cleared under the same submission

K151758 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI c508b80a-48d7-46fa-b5ea-fc8cbea98e36 36 fields · synced Jun 8, 2026