Film Ev-58

FDA UDI

Class I (US FDA UDI)

by Flow X-Ray Corp.

Identity

Trade Name: FILM EV-58 FDA UDI
Generic Name: Dental x-ray film, non-screen FDA UDI
Device Name: F Speed, Size 2, 100 Single Film Packets. FDA UDI
Model / Reference: 18630E FDA UDI
Description: F Speed, Size 2, 100 Single Film Packets. FDA UDI

Identifiers

Primary DI / UDI-DI: 00812045030382 FDA UDI
FDA Product Code: IWZ FDA UDI
GMDN Term: Dental x-ray film, non-screen FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1840 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental x-ray film, non-screen

Film Ev-58 by Flow X-Ray Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental x-ray film, non-screen.

INSIGHT — CARESTREAM HEALTH, INC. · Class I
D-Speed — CARESTREAM HEALTH, INC. · Class II
Henry Schein — HENRY SCHEIN, INC. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
D-Speed — CARESTREAM HEALTH, INC. · Class I
Ultra-speed — CARESTREAM HEALTH, INC. · Class I
Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I

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: Flow X-Ray Corp.

Sources (1)

FDA UDI cf341454-f8a6-44fb-96cf-d912b5f66a6e 33 fields · synced Jun 1, 2026