CARESTREAM HEALTH, INC.

Address:1049 West Ridge Road,Rochester,NY,14615,US

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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) (8) Screen, intensifying, radiographic (EAM) (2) Cassette, radiographic film (IXA) (1)

Premarket Exempt

No Yes

Clear

Green X-ray Film WB - 40889971096216 Catalog Number : 1096213

Device Description : 100SH 35X35-14X14 GREEN X-RAY WB 8389

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Imaging Plate - 40889971098913 Catalog Number : 1098912

Device Description : CR SEMI-FIN PLATE CEPH 18X24CM

Device Class : 1

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 1

DRYVIEW DVC Laser Imaging Film - 40889971099118 Catalog Number : 1099118

Device Description : 100SH 5800 20X25CM (8X10IN) DVC CE

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

DRYVIEW DVB Laser Imaging Film - 40889971102634 Catalog Number : 1102631

Device Description : 125SH 35X28CM (14X11IN) DVB

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 125

MIN-R 2 Cassette with MIN-R EV 150 Screen - 40889971117034 Catalog Number : 1117035

Device Description : 18X24CM MIN-R2 CASS W/EV 150 SCR

Device Class :

Duns Number: 793169512

Premarket Exempt : No

Product Code : IXA, EAM

Prescription Use : No

Device Count : 150

HALF Blue X-ray Film WB - 40889971118345 Catalog Number : 1118348

Device Description : 100SH 10X12IN HALF BLUE X-RAY

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

INSIGHT - 40889971124988 Catalog Number : 1124981

Device Description : INSIGHT 100PKT 24x40 film IP11

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Oncology EDR2 Film - 40889971161761 Catalog Number : 1161769

Device Description : ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

INSIGHT - 40889971163406 Catalog Number : 1163401

Device Description : INSIGHT 150PKT 30.5x40.5 film IP21

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 150

INSIGHT - 40889971169149 Catalog Number : 1169143

Device Description : INSIGHT 25PKT 57x76 film IO41

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 25

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