Identity
- Trade Name
- SeptAlign FDA UDI
- Generic Name
- Nasal cartilage support implant, bioabsorbable FDA UDI
- Model / Reference
- FG-0032 FDA UDI
Identifiers
- Catalog Number
- SPLN001 FDA UDI
- Primary DI / UDI-DI
- 00860011696308 FDA UDI
- 510(k) Number
- K233569 FDA UDI
- FDA Product Code
- NHB FDA UDI
- GMDN Term
- Nasal cartilage support implant, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 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: Nasal cartilage support implant, bioabsorbableNasal cartilage support implant introducer
SeptAlign by Spirair — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal cartilage support implant, bioabsorbable.
- LATERA — Stryker Corp. · Class II
- LATERA — Stryker Corp. · Class II
- LATERA — Stryker Corp. · Class II
- LATERA — Stryker Corp. · Class II
- SeptAlign — Spirair · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spirair
Sources (1)
- FDA UDI 035747a0-2628-4205-abd1-fad4fe4aa059 34 fields · synced May 29, 2026