Identity
- Trade Name
- Entity SDXL Plus Nasopharyngoscope FDA UDI
- Generic Name
- Flexible fibreoptic nasopharyngoscope FDA UDI
- Model / Reference
- F015692 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858119004200 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible fibreoptic nasopharyngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
Category: Flexible fibreoptic nasopharyngoscope
Entity SDXL Plus Nasopharyngoscope by Optim Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- InstaClear — Gyrus Acmi, Inc. · Class II
- MACHIDA — MACHIDA ENDOSCOPE CO., LTD. · Class II
- InstaClear — Gyrus Acmi, Inc. · Class II
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
- Optim Llc
Sources (1)
- FDA UDI 9db616ef-c53a-4997-80d2-19aaede41110 32 fields · synced May 30, 2026