Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including Prestige Coaxial-Plus Ophthalmoscope (#11735), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 60-Minute Power Handle(s) -- C-Cell Convertible, Hard Storage Case, Fixation Cards, C-Cell Battery Converter Accessory; Nickel-Cadmium (#72300) FDA UDI
- Model / Reference
- 901026 FDA UDI
- Description
- Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including Prestige Coaxial-Plus Ophthalmoscope (#11735), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 60-Minute Power Handle(s) -- C-Cell Convertible, Hard Storage Case, Fixation Cards, C-Cell Battery Converter Accessory; Nickel-Cadmium (#72300) FDA UDI
Identifiers
- Catalog Number
- 18335-C FDA UDI
- Primary DI / UDI-DI
- 00732094016505 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 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
Yes
FDA UDI
Category: Otoscope, direct
Welch Allyn, Inc. by Welch Allyn, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoscope, direct.
- TytoHome — TYTO CARE LTD · Class II
- TytoHome — TYTO CARE LTD · Class II
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
- BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
- Firefly — Firefly Global · Class I
- Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
- BV Medical — Medical, Inc. · Class I
- ENT POCKET LIGHT — C F M TECHNOLOGIES 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI a4c6b0a3-3c01-4ca2-b4e1-938863d68c9c 35 fields · synced May 30, 2026