Large OtoSight Speculum Tip QTY 20

FDA UDI

Class II (US FDA UDI)

by Photonicare, Inc.

Identity

Trade Name: Large OtoSight Speculum Tip QTY 20 FDA UDI
Generic Name: Ear speculum, single-use FDA UDI
Device Name: 20 pack of Large OtoSight Speculum Tips FDA UDI
Model / Reference: Large FDA UDI
Description: 20 pack of Large OtoSight Speculum Tips FDA UDI

Identifiers

Primary DI / UDI-DI: 10850013784070 FDA UDI
510(k) Number: K191804 FDA UDI
FDA Product Code: QJG FDA UDI
GMDN Term: Ear speculum, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ear speculum, single-use

Large OtoSight Speculum Tip QTY 20 by Photonicare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K191804 also covers:

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: Photonicare, Inc.

Sources (1)

FDA UDI e55c63dd-0830-4182-8e5b-6d106ab94bcd 34 fields · synced May 30, 2026