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Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name
Welch Allyn, Inc. FDA UDI
Generic Name
Ophthalmic/otologic diagnostic set FDA UDI
Device Name
Welch Allyn PanOptic iExaminer Digital Imaging Kit; PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820 ), Rechargeable 120-Minute Power Handle(s), Soft Storage Case, iExaminer Adapter (#11840); Lithium-Ion (#71960) Battery; IEC Plug Type-B FDA UDI
Model / Reference
901090 FDA UDI
Description
Welch Allyn PanOptic iExaminer Digital Imaging Kit; PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820 ), Rechargeable 120-Minute Power Handle(s), Soft Storage Case, iExaminer Adapter (#11840); Lithium-Ion (#71960) Battery; IEC Plug Type-B FDA UDI

Identifiers

Catalog Number
11842 FDA UDI
Primary DI / UDI-DI
00732094155402 FDA UDI
FDA Product Code
HLI 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
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welch Allyn, Inc.

Sources (1)

  • FDA UDI 02643ca5-b7e2-44d3-b985-03db45ccc4aa 36 fields · synced Jun 1, 2026