Identity
- Trade Name
- Nasal Implant FDA UDI
- Generic Name
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
- Device Name
- Nasal Style 4 Size 4 FDA UDI
- Model / Reference
- D FDA UDI
- Description
- Nasal Style 4 Size 4 FDA UDI
Identifiers
- Catalog Number
- 402-404 FDA UDI
- Primary DI / UDI-DI
- B490402404 FDA UDI
- 510(k) Number
- K021418 FDA UDI
- FDA Product Code
- FZE FDA UDI
- GMDN Term
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3680 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
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
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Nasal cartilage support implant, non-bioabsorbable
Nasal Implant by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal cartilage support implant, non-bioabsorbable.
- Nasal Implant — Hanson Medical, Inc. · Class II
- Nasal Implant — Implantech Associates, Inc. · Class II
- Nasal Implant — Implantech Associates, Inc. · Class II
- Nasal Implant — Implantech Associates, Inc. · Class II
- Anatomical Nasal Implant — Implantech Associates, Inc. · Class II
- MEDPOR — Stryker Leibinger · Class II
- Nasal Implant — Hanson Medical, Inc. · Class II
- Shirakabe Nasal Implant — Implantech Associates, Inc. · Class II
Cleared under the same submission
K021418 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 II | Pending data |
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Manufacturer
- Manufacturer
- Aart
Sources (1)
- FDA UDI 63569b70-aa13-4775-882b-245d3e3797d1 36 fields · synced Jun 1, 2026