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) (6) Screen, intensifying, radiographic (EAM) (3) System,x-ray,extraoral source,digital (MUH) (1)

Premarket Exempt

No Yes

Clear

CS 7200 - 40889971067513 Catalog Number : 1067511

Device Description : Hygienic Sheaths #2 - 200 Pcs

Device Class :

Duns Number: 793169512

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 200

T-MAT H/RA - 40889971067520 Catalog Number : 1067529

Device Description : T-MAT H/RA 50SH 15x30cm film

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 50

Imaging Plate - 40889971067544 Catalog Number : 1067545

Device Description : Imaging Plate #0 - 4 Pcs

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

Imaging Plate - 40889971067551 Catalog Number : 1067552

Device Description : Imaging Plate #1 - 4 Pcs

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

Imaging Plate - 40889971067568 Catalog Number : 1067560

Device Description : Imaging Plate #2 - 4 Pcs

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

DRYVIEW DVB+ Laser Imaging Film - 40889971069593 Catalog Number : 1069590

Device Description : 125SH 35X43CM (14X17IN) DVB+ CE

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 125

INSIGHT - 40889971079080 Catalog Number : 1079086

Device Description : INSIGHT 150PKT 30.5x40.5 film IP22 PR

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 150

Full Blue X-ray Film WB - 40889971081724 Catalog Number : 1081728

Device Description : 100SH 8X10IN BLUE X-RAY WB

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Green X-ray Film WB - 40889971084473 Catalog Number : 1084474

Device Description : 100SH 11X14IN GREEN X-RAY WB

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

Half Blue X-ray Film WB - 40889971088679 Catalog Number : 1088673

Device Description : 100SH 8X10IN HALF BLUE X-RAY

Device Class :

Duns Number: 793169512

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : No

Device Count : 100

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