SunMed

FDA UDI

Class I (US FDA UDI)

by SunMed

Identity

Trade Name: SunMed FDA UDI
Generic Name: Laryngoscope handle, reusable FDA UDI
Device Name: LED F/O PENLITE S/S HANDLE FDA UDI
Model / Reference: 5-0246-80 FDA UDI
Description: LED F/O PENLITE S/S HANDLE FDA UDI

Identifiers

Catalog Number: 5-0246-80 FDA UDI
Primary DI / UDI-DI: 10889483022474 FDA UDI
FDA Product Code: CCW FDA UDI
GMDN Term: Laryngoscope handle, reusable 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 129 Millimeter FDA UDI

Category: Laryngoscope handle, reusable

SunMed by SunMed — 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: SunMed

Sources (1)

FDA UDI 8a78daa4-2e67-49ae-a64c-be0a3c59836f 36 fields · synced May 31, 2026