DX-42 BITE CHEX

GUDID 00812045030634

D Speed, Size 3, 100 Single Film Paper Packets

Flow X Ray Corporation

Dental x-ray film, non-screen
Primary Device ID00812045030634
NIH Device Record Key45a80f26-e639-4944-9c82-07170b65e769
Commercial Distribution StatusIn Commercial Distribution
Brand NameDX-42 BITE CHEX
Version Model Number18060
Company DUNS010016319
Company NameFlow X Ray Corporation
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812045030634 [Primary]
GS110812045030631 [Package]
Package: [50 Units]
In Commercial Distribution
GS120812045030638 [Unit of Use]

FDA Product Code

IWZFilm, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

On-Brand Devices [DX-42 BITE CHEX]

H665180601D Speed Size 3 film in paper packets. 100 films per box
00812045030634D Speed, Size 3, 100 Single Film Paper Packets

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