Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Welch Allyn 3.5V Diagnostic Set with PanOptic Plus LED Ophthalmoscope, MacroView Plus LED Otoscope for iExaminer, Universal Desk Charger, and two Premium Lithium Ion Plus USB Rechargeable Power Handles FDA UDI
- Model / Reference
- 901026 FDA UDI
- Description
- Welch Allyn 3.5V Diagnostic Set with PanOptic Plus LED Ophthalmoscope, MacroView Plus LED Otoscope for iExaminer, Universal Desk Charger, and two Premium Lithium Ion Plus USB Rechargeable Power Handles FDA UDI
Identifiers
- Catalog Number
- 71-PM3LDE-US FDA UDI
- Primary DI / UDI-DI
- 00732094347104 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 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 II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 9920576d-c095-4253-b7a3-c05b314643e3 35 fields · synced May 31, 2026