Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Welch Allyn 3.5 V Halogen HPX Ophthalmic Desk Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter on Corneal Viewing Lens (#11820), Prestige Coaxial-Plus Ophthalmoscope (#11735), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 120-Minute Power Handle(s), Universal Desk Charger, Hard Storage Case, Training Fundus Eyebox (#SM2383), Fixation Cards, Charging Well Adapter; 2 Lithium-Ion (#71960) Batteries; IEC Plug Type-A FDA UDI
- Model / Reference
- 901026 FDA UDI
- Description
- Welch Allyn 3.5 V Halogen HPX Ophthalmic Desk Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter on Corneal Viewing Lens (#11820), Prestige Coaxial-Plus Ophthalmoscope (#11735), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 120-Minute Power Handle(s), Universal Desk Charger, Hard Storage Case, Training Fundus Eyebox (#SM2383), Fixation Cards, Charging Well Adapter; 2 Lithium-Ion (#71960) Batteries; IEC Plug Type-A FDA UDI
Identifiers
- Catalog Number
- 18365-SDP5 FDA UDI
- Primary DI / UDI-DI
- 00732094016383 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set 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: Ophthalmic/otologic diagnostic set
Welch Allyn, Inc. by Welch Allyn, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI faef819c-95d9-4a7b-8e5e-20eb0c643ce0 35 fields · synced May 30, 2026