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

Screen, intensifying, radiographic (EAM) (5) Film, radiographic (IWZ) (3) CAMERA, SURGICAL AND ACCESSORIES (KQM) (1) System,x-ray,extraoral source,digital (MUH) (1)

Premarket Exempt

No Yes

Clear

DRYVIEW DVB Laser Imaging Film - 40889971050843 Catalog Number : 1050848

Device Description : 125SH 35X43CM DVB (2PK) CE

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 125

D-Speed - 40889971051260 Catalog Number : 1051267

Device Description : D-Speed 100 PKT 30.5X40.5MM FILM

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

CS 7600 Smart Plate - 40889971059952 Catalog Number : 1059955

Device Description : CS7600 SMART PLATE SIZE 0 V2 - 4 PCS

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40889971059969 Catalog Number : 1059963

Device Description : CS7600 SMART PLATE SIZE 1 V2 - 4 PCS

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40889971059983 Catalog Number : 1059989

Device Description : CS7600 SMART PLATE SIZE 2 V2 - 4 PCS

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40889971059990 Catalog Number : 1059997

Device Description : CS7600 SMART PLATE SIZE 3 V2 - 4 PCS

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40889971060019 Catalog Number : 1060011

Device Description : CS7600 SMART PLATE SIZE 4 V2 - 2 PCS

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 2

Medical X-ray Green / MXG Film - 40889971065823 Catalog Number : 1065820

Device Description : Medl X-ray Green/MXG Film 10X12in 100SH

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Hygienic Sheaths - 40889971067490 Catalog Number : 1067495

Device Description : Hygienic Sheaths #0 - 200 Pcs

Device Class :

Duns Number: 793169512

Premarket Exempt : No

Product Code : KQM

Prescription Use : Yes

Device Count : 200

CS 7200 - 40889971067506 Catalog Number : 1067503

Device Description : Hygienic Sheaths #1 - 200 Pcs

Device Class :

Duns Number: 793169512

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 200

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