Shirakabe Nasal Implant
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Shirakabe Nasal Implant FDA UDI
- Generic Name
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
- Device Name
- Nasal Implant FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDSNI-L1 EUDAMEDSize: Large, Style 1 FDA UDI
- Description
- Nasal Implant FDA UDI
Identifiers
- Catalog Number
- SNI-L1 FDA UDI
- Primary DI / UDI-DI
- M724SNIL11 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724SNIL11 EUDAMED
- 510(k) Number
- K941960 FDA UDI
- FDA Product Code
- FZE FDA UDI
- EMDN Code
- P010199 FACIAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3680 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nasal cartilage support implant, non-bioabsorbable
Shirakabe Nasal Implant by Implantech Associates, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasal cartilage support implant, non-bioabsorbable.
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- Nasal Implant — Hanson Medical, Inc. · Class II
- Nasal Implant — Hanson Medical, Inc. · Class II
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- Nasal Implant — Hanson Medical, Inc. · Class II
Cleared under the same submission
K941960 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (2)
- FDA UDI 4e0078dd-1786-45df-8a2e-242a7a0caa4b 36 fields · synced Jul 9, 2026
- EUDAMED eb214340-c876-41cf-bf82-0b947e2f294d 61 fields · synced Jul 9, 2026