Insight

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: INSIGHT FDA UDI
Generic Name: Dental x-ray film, non-screen FDA UDI
Device Name: INSIGHT 130PKT 30.5x40.5 film IP22 FDA UDI
Model / Reference: INSIGHT FDA UDI
Description: INSIGHT 130PKT 30.5x40.5 film IP22 FDA UDI

Identifiers

Catalog Number: 1798628 FDA UDI
Primary DI / UDI-DI: 40889971798622 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental x-ray film, non-screen

Insight by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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FILM DSS-58 D ADULT SINGLE FILM BUTTERFLY PACKETS D SPEED — Flow X-Ray Corp. · Class I
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DV-57 ADULT TWIN VALUE PAK — Flow X-Ray Corp. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
BUTTERFLY BARRIER FILM FSS-54 — Flow X-Ray Corp. · Class I
X-Ray Film F Speed FS-22 #2 — Flow X-Ray Corp. · Class I
FV-58 ADULT 50/BOX FRESH PAK — Flow X-Ray Corp. · 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: Carestream Health, Inc.

Sources (1)

FDA UDI 92db2f6b-7b88-4224-8bd1-b3921cf0b9b9 35 fields · synced Jun 7, 2026