Identity
- Trade Name
- PENTAX FDA UDI
- Generic Name
- Laryngostroboscope FDA UDI
- Device Name
- Carrying Case For VNL-ST VE-B11 FDA UDI
- Model / Reference
- VE-B11 FDA UDI
- Description
- Carrying Case For VNL-ST VE-B11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333128174 FDA UDI
- FDA Product Code
- EQL FDA UDI
- GMDN Term
- Laryngostroboscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4750 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laryngostroboscope
Pentax by Hoya Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laryngostroboscope.
- VIDEO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class I
- JEDMED — JEDMED Instrument Company · Class I
- VIDEO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class I
- LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class I
- Henke Sass Wolf — H & A Mui Enterprises Inc · Class I
- VIDEO LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class I
- JEDMED — JEDMED Instrument Company · Class I
- LARYNGOSTROBOSCOPE — PENTAX of America, Inc. · Class I
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
- Hoya Corporation
Sources (1)
- FDA UDI b40d1ef0-7b17-4e7e-a7ae-2425a75b6edd 33 fields · synced Jun 8, 2026