Identity
- Trade Name
- NEONAIL FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Device Name
- End cap D12x10 mm FDA UDI
- Model / Reference
- 932.201 FDA UDI
- Description
- End cap D12x10 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899893203260 FDA UDI
- 510(k) Number
- K141103 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail end-cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone nail end-cap
Neonail by Neoortho Produtos Ortopédicos S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone nail end-cap.
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Cleared under the same submission
K141103 also covers:
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
- NEONAIL — Neoortho Produtos Ortopédicos S/A.
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
- Neoortho Produtos Ortopédicos S/A.
Sources (1)
- FDA UDI 5f6c2a3d-ab80-48aa-8700-5766d7a691d5 35 fields · synced May 30, 2026