Identity
- Trade Name
- TurbAlign FDA UDI
- Generic Name
- Intranasal splint, biodegradable FDA UDI
- Model / Reference
- FG-0019 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011696339 FDA UDI
- 510(k) Number
- K243655 FDA UDI
- FDA Product Code
- LYA FDA UDI
- GMDN Term
- Intranasal splint, 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intranasal splint, biodegradable
TurbAlign by Spirair — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Husteon MeshNasal — MediFab Co., Ltd · Class I
Cleared under the same submission
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
- Spirair
Sources (1)
- FDA UDI 92ab1630-db62-460d-a841-5a20b2015ce5 33 fields · synced May 30, 2026