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 FSS-53 - 00812045030528 Catalog Number :

Device Description : FILM FSS-53 D CHILD DOUBLE FILM BUTTERFLY PACKETS F SPEED, 75pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM TRUE BLUE CEPHALOMETRIC BLUE FILM 8 X 10, - 00812045030535 Catalog Number :

Device Description : FILM TRUE BLUE CEPHALOMETRIC BLUE FILM 8 X 10, FILM, EXTRAORAL CEPHALOMETRIC

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM CEPHALOMETRIC - 00812045030542 Catalog Number :

Device Description : FILM CEPHALOMETRIC GREEN SENSITIVE 8 X 10, 100pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM CEPHALOMETRIC - 00812045030559 Catalog Number :

Device Description : FILM CEPHALOMETRIC GREEN SENSITIVE 8 X 10, 100pcs/box

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM DV-58 PET DENT WOLF D SPEED SIZE 2 - 00812045030566 Catalog Number :

Device Description : FILM DV-58 PET DENT WOLF D SPEED SIZE 2,FILM INTRAORAL X-RAY

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM DV-58 PET DENT WOLF D SPEED SIZE 3 - 00812045030573 Catalog Number :

Device Description : FILM DV-58 PET DENT WOLF D SPEED SIZE 3, FILM INTRAORAL X-RAY

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM DV-58 PET DENT WOLF D SPEED SIZE 4 - 00812045030580 Catalog Number :

Device Description : FILM DV-58 PET DENT WOLF D SPEED SIZE 4, FILM INTRAORAL X-RAY

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

FILM DV-58 PET DENT WOLF D SPEED SIZE 4 - 00812045030597 Catalog Number :

Device Description : Flow Film DV-58,D SPEED SIZE 2, FILM INTRAORAL X-RAY 50 pack

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM DV-58 PET DENT WOLF D SPEED SIZE 5 - 00812045030603 Catalog Number :

Device Description : FILM DV-58 PET DENT WOLF D SPEED SIZE 5, FILM, EXTRAORAL PANORAMIC

Device Class : 1

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 1

FILM KOPY KAT DUPLICATING FILM, 5 X 12 - 00812045030610 Catalog Number :

Device Description : FILM FLOW KOPY KAT DUPLICATING FILM, 5 X 12' 50 pcs/box

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

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