Identity
- Trade Name
- Papevero Speculum 70mm FDA UDI
- Generic Name
- Nasal speculum, reusable FDA UDI
- Device Name
- Speculum FDA UDI
- Model / Reference
- 99-200-17 FDA UDI
- Description
- Speculum FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810009465348 FDA UDI
- FDA Product Code
- EPY FDA UDI
- GMDN Term
- Nasal speculum, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.1800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Papevero Speculum 70mm by Mizuho America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Mizuho America, Inc.
Sources (1)
- FDA UDI 7b0574e9-560d-4ea1-b44a-bcc751922668 34 fields · synced Jun 6, 2026