Identity
- Trade Name
- SPIWay FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- SPIWay Endonasal Access Guide Size Large FDA UDI
- Model / Reference
- SP004 FDA UDI
- Description
- SPIWay Endonasal Access Guide Size Large FDA UDI
Identifiers
- Catalog Number
- SP004 FDA UDI
- Primary DI / UDI-DI
- 00860003136409 FDA UDI
- 510(k) Number
- K180141 FDA UDI
- FDA Product Code
- LYA FDA UDI
- GMDN Term
- Intranasal splint, non-biodegradable 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intranasal splint, non-biodegradable
SPIWay by Spiway, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
Cleared under the same submission
K180141 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
- Spiway, LLC
Sources (1)
- FDA UDI ca4af77a-8ba2-4294-9590-24641d7cec4e 36 fields · synced May 30, 2026