PrimeSight

FDA UDI

Class I (US FDA UDI)

by SCHÖLLY FIBEROPTIC GmbH

Identity

Trade Name: PrimeSight FDA UDI
Generic Name: Rigid optical laryngopharyngoscope FDA UDI
Device Name: Laryngoscope 10 x 173 mm, 70° FDA UDI
Model / Reference: 02-4317 FDA UDI
Description: Laryngoscope 10 x 173 mm, 70° FDA UDI

Identifiers

Primary DI / UDI-DI: 04250480107362 FDA UDI
FDA Product Code: CCW FDA UDI
GMDN Term: Rigid optical laryngopharyngoscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Rigid optical laryngopharyngoscope

PrimeSight by SCHÖLLY FIBEROPTIC GmbH — 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: SCHÖLLY FIBEROPTIC GmbH

Sources (1)

FDA UDI 9d6beb82-bbb3-45f8-b05f-4725668f3e0e 36 fields · synced May 30, 2026