KaWe

FDA UDI

Class I (US FDA UDI)

by Medical, Inc.

Identity

Trade Name: KaWe FDA UDI
Generic Name: Ear speculum, single-use FDA UDI
Device Name: Specula, Disposable, 2.5mm (100 per pack, gray) for PICCOLIGHT® FDA UDI
Model / Reference: 61-910-100 FDA UDI
Description: Specula, Disposable, 2.5mm (100 per pack, gray) for PICCOLIGHT® FDA UDI

Identifiers

Primary DI / UDI-DI: 00845821020871 FDA UDI
FDA Product Code: FXG FDA UDI
GMDN Term: Ear speculum, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ear speculum, single-use

KaWe by Medical, 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: Medical, Inc.

Sources (1)

FDA UDI 51f6eace-8d0b-4e1e-8ed7-182d4510e35f 34 fields · synced Jun 8, 2026