Peri-Pyriform™
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Peri-Pyriform™ FDA UDI
- Generic Name
- Nasal cartilage support implant, non-bioabsorbable FDA UDI
- Device Name
- Premaxillary Implant FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDBPI-S EUDAMEDSize: Small FDA UDI
- Description
- Premaxillary Implant FDA UDI
Identifiers
- Catalog Number
- BPI-S FDA UDI
- Primary DI / UDI-DI
- M724BPIS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724BPIS1 EUDAMED
- 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
Peri-Pyriform™ by Implantech Associates, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nasal cartilage support implant, non-bioabsorbable.
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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 e4d61ad7-7064-44b0-af73-da36f3354817 35 fields · synced Oct 7, 2026
- EUDAMED 4b4ca5b4-02d5-45ae-b2a7-39231835df2a 61 fields · synced Jun 18, 2026