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

PATTERSON D-SPEED - H66518200P1 Catalog Number :

Device Description : D SPEED ADULT SIZE 2 FILM. 150 FILMS PER BOX

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 150

SAFCO D SPEED FILM - H66518200SF1 Catalog Number :

Device Description : D-SPEED SIZE 2 SINGLE FILMS. 150 FILMS PER BOX

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 150

Silver D: DV-57 - H665182011 Catalog Number :

Device Description : Value Pak. D Speed Size 2 Adult Film in vinyl packet. Two films per packet. 13 Value Pak. D Speed Size 2 Adult Film in vinyl packet. Two films per packet. 130 films per box

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 130

SAFCO D SPEED FILM - H66518201SF1 Catalog Number :

Device Description : D SPEED SIZE 2, DOUBLE FILMS. 2 FILMS PER PACKET. 130 FILMS PER BOX.

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 130

PATTERSON D SPEED - H66518202P1 Catalog Number :

Device Description : D SPEED SIZE 2 ADULT FILM. 2 FILMS PER PACKET, 130 PACKETS PER BOX

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 130

Silver D: DV-58 - H665182041 Catalog Number : 18204

Device Description : Econo Pak D Speed Size 2 Adult Film in vinyl packets.600 films per box.

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 600

SILVER D: DV-54 PEDO ECONO PAK - H665182061 Catalog Number : 18206

Device Description : D SPEED SIZE 0 CHILD FILM, ECONO PAK, 400 FILMS PER BOX

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 400

XPRESS: FV-54 ECONO PAK - H665182071 Catalog Number :

Device Description : F SPEED SIZE 0 CHILD FILM, 400 SINGLE FILMS PER BOX

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 400

XPRESS: FV-58 ECONO PAK - H665182151 Catalog Number :

Device Description : F SPEED SIZE 2 ADULT FILM, 600 FILMS PER BOX.

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 600

SILVER D: DV-54 PEDO PAK - H665182351 Catalog Number :

Device Description : D SPEED SIZE 0 CHILD FILM, 100 SINGLE FILMS PER BOX

Device Class :

Duns Number: 010016319

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

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