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Hopkins Medical Products®

FDA UDI

Class I (US FDA UDI)

by Hopkins Uniform Company

Identity

Trade Name
Hopkins Medical Products® FDA UDI
Generic Name
Ear canal lavage system FDA UDI
Device Name
Welch Allyn Ear Wash System Eartips PK25 FDA UDI
Model / Reference
549360 FDA UDI
Description
Welch Allyn Ear Wash System Eartips PK25 FDA UDI

Identifiers

Catalog Number
549360 FDA UDI
Primary DI / UDI-DI
00817643021848 FDA UDI
FDA Product Code
KYZ FDA UDI
GMDN Term
Ear canal lavage system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6960 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ear canal lavage system

Hopkins Medical Products® by Hopkins Uniform Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ear canal lavage system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hopkins Uniform Company

Sources (1)

  • FDA UDI 45abe79e-cad4-46c8-bd10-c9ba3cc09ae1 35 fields · synced May 30, 2026