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Welch Allyn, Inc.

FDA UDI

Class I (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 Elite 3.5 V Halogen HPX Spot Retinoscope; Power Handle Not Included FDA UDI
Model / Reference
901024 FDA UDI
Description
Welch Allyn Elite 3.5 V Halogen HPX Spot Retinoscope; Power Handle Not Included FDA UDI

Identifiers

Catalog Number
18300 FDA UDI
Primary DI / UDI-DI
00732094087710 FDA UDI
FDA Product Code
HKM FDA UDI
GMDN Term
Ophthalmic/otologic diagnostic set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1780 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

Similar devices

Also classified as Ophthalmic/otologic diagnostic set.

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 ab7c1a5b-889f-44f4-8c98-134815a6f8fa 35 fields · synced May 30, 2026