Plastcare USA

Plastcare USA

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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

Evacuator, Oral Cavity (EHZ) (4) Mask, Surgical (FXX) (4) File, Pulp Canal, Endodontic (EKS) (1) Mouthpiece, Saliva Ejector (DYN) (1)

Premarket Exempt

No Yes

Clear

Plastcare - D915CLB1 Catalog Number :

Device Description : Saliva Ejector Clear with Blue Tip

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Plastcare - D915E10011 Catalog Number :

Device Description : Surgical Aspirator Tips Blue Small Vented 1/16" Diam

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 25

Plastcare - D915E10021 Catalog Number :

Device Description : Surgical Aspirator Tips White Medium Vented 1/8" Diam

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 25

Plastcare - D915E10031 Catalog Number :

Device Description : Surgical Aspirator Tips Green Large Vented 1/4" Diam

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 25

Plastcare - D915HVE011 Catalog Number :

Device Description : Vented Evacuation Tips White Color

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 100

Verge - D915K21061 Catalog Number :

Device Description : Stainless Steel K File Size 6 Length 21

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 6

Sentinel - D915MBK21 Catalog Number :

Device Description : Earloop Mask - Black ASTM Level 2

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Sentinel - D915MBL21 Catalog Number :

Device Description : Earloop Mask - Blue ASTM Level 2

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Sentinel - D915MPI21 Catalog Number :

Device Description : Earloop Mask - Pink ASTM Level 2

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Sentinel - D915MWH21 Catalog Number :

Device Description : Earloop Mask - White ASTM Level 2

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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