CARESTREAM DENTAL LLC

Address:3625 Cumberland Boulevard,Atlanta,GA,30339,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) (7) Camera, Surgical And Accessories (KQM) (3)

Premarket Exempt

No Yes

Clear

Hygienic Sheath - 40192155942507 Catalog Number : 5942503

Device Description : HYGIENIC SHEATHS #0 - 200 PCS

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 200

CS 7600 Smart Plate - 40192155942514 Catalog Number : 5942511

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

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

Hygienic Sheath - 40192155942521 Catalog Number : 5942529

Device Description : HYGIENIC SHEATHS #1 - 200 PCS

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 200

CS 7600 Smart Plate - 40192155942538 Catalog Number : 5942537

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

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40192155942545 Catalog Number : 5942545

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

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40192155942552 Catalog Number : 5942552

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

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

CS 7600 Smart Plate - 40192155942569 Catalog Number : 5942560

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

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

Hygienic Sheath - 40192155942576 Catalog Number : 5942578

Device Description : HYGIENIC SHEATHS #2 - 200 PCS

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 200

Imaging Plate - 40192155942583 Catalog Number : 5942586

Device Description : IMAGING PLATE #0 - 4 PCS

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : Yes

Device Count : 4

Imaging Plate - 40192155942590 Catalog Number : 5942594

Device Description : IMAGING PLATE #1 - 4 PCS

Device Class :

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : EAM

Prescription Use : No

Device Count : 4

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