Identity
- Trade Name
- AART Nasal Implant Sizer FDA UDI
- Generic Name
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
- Device Name
- Szr - Nasal Sty 2 NS FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Szr - Nasal Sty 2 NS FDA UDI
Identifiers
- Catalog Number
- 402-202-2A FDA UDI
- Primary DI / UDI-DI
- B4904022022A0 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
- Not 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
No
FDA UDI
Dry Heat Sterilization FDA UDI
AART Nasal Implant Sizer by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 66a2a87a-5ad3-4bc7-b75b-cbc9c1a6edde 37 fields · synced May 30, 2026