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True Blue 612

FDA UDI

Class I (US FDA UDI)

by Flow X-Ray Corp.

Identity

Trade Name
TRUE BLUE 612 FDA UDI
Generic Name
Dental x-ray film, non-screen FDA UDI
Device Name
BLUE SENSITIVE PANORAMIC FILM 6X12", 50 SHEETS PER BOX FDA UDI
Model / Reference
18096 FDA UDI
Description
BLUE SENSITIVE PANORAMIC FILM 6X12", 50 SHEETS PER BOX FDA UDI

Identifiers

Primary DI / UDI-DI
H665180961 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental x-ray film, non-screen

True Blue 612 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flow X-Ray Corp.

Sources (1)

  • FDA UDI 69f82ba1-e1d7-46b6-b9cf-83fad2ee278b 34 fields · synced May 30, 2026