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
- 20643169232000 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
- Length — 19.0 Millimeter FDA UDIWidth — 16.0 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.
- ALAR® — MEDTRONIC XOMED, INC. · Class I
- ALAR® — MEDTRONIC XOMED, INC. · Class I
Cleared under the same submission
K151758 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 7ac3ff95-dcac-4f84-943f-e6efabd87969 36 fields · synced Jun 8, 2026