FLOW X RAY CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Film, Radiographic (IWZ) (10)

Premarket Exempt

No Yes

Clear

FILM INTRAORAL X-RAY - 00812045030023 Catalog Number :

Device Description : Flow Adult Paper DX-58 150pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM DX-54 NO. 0 CHILD PAPER FILM D SPEED - 00812045030047 Catalog Number :

Device Description : FILM INTRAORAL X-RAY, FILM DX-54 NO. 0 CHILD PAPER FILM D SPEED, 100pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED - 00812045030061 Catalog Number :

Device Description : FILM INTRAORAL X-RAY, FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED, 100pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

True Blue 512 - 5 x 12" Blue Sensitive Panoramic Film - 00812045030092 Catalog Number :

Device Description : True Blue 512 - 5 x 12" Blue Sensitive Panoramic Film

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

FILM 5X12 GREEN TEAM GREEN SENSITIVE PANORAMIC - 00812045030108 Catalog Number :

Device Description : FILM, EXTRAORAL PANORAMIC, FILM 5X12 GREEN TEAM GREEN SENSITIVE PANORAMIC, 100pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

True Blue 612 - 6 x 12" Blue Sensitive Panoramic Film - 00812045030122 Catalog Number :

Device Description : True Blue 612 - 6 x 12" Blue Sensitive Panoramic Film, Extraoral

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

Green Team 512 - 5 x 12" Green Sensitive Panoramic Film - 00812045030139 Catalog Number :

Device Description : Green Team 512 - 5 x 12" Green Sensitive Panoramic Film, Extraoral

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

FILM 6X12 TRUE BLUE SENSITIVE PANO - 00812045030146 Catalog Number :

Device Description : FILM, EXTRAORAL PANORAMIC, FILM 6X12 TRUE BLUE SENSITIVE PANO

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM 6 X 12 GREEN SENSITIVE PANORAMIC - 00812045030153 Catalog Number :

Device Description : FILM, EXTRAORAL PANORAMIC, FILM 6 X 12 GREEN SENSITIVE PANORAMIC

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

Green Team 612 - 6 x 12" Green Sensitive Panoramic Film - 00812045030160 Catalog Number :

Device Description : Green Team 612 - 6 x 12" Green Sensitive Panoramic Film, Extraoral

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

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