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

Dispenser, Liquid Medication (KYX) (5) Indicator, Physical/Chemical Sterilization Process (JOJ) (3) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Material, Impression Tray, Resin (EBH) (1)

Premarket Exempt

No Yes

Clear

Plastcare - D915RIT35651 Catalog Number :

Device Description : ( 3 1/2" x 5 1/4") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT43121 Catalog Number :

Device Description : (4 1/4" x 12") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT44041 Catalog Number :

Device Description : Gauze Non Woven Sponges 4 x 4 Inch.

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

Plastcare - D915RIT50101 Catalog Number :

Device Description : 5oz Disposable Plastic Dental Cup Blue

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 50

Plastcare - D915RIT50151 Catalog Number :

Device Description : 5oz Disposable Plastic Dental Cup Pink

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 50

Plastcare - D915RIT50201 Catalog Number :

Device Description : 5oz Disposable Plastic Dental Cup Green

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 50

Plastcare - D915RIT50251 Catalog Number :

Device Description : 5oz Disposable Plastic Dental Cup White

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 50

Plastcare - D915RIT50301 Catalog Number :

Device Description : 5oz Disposable Plastic Dental Cup Lavender

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : KYX

Prescription Use : No

Device Count : 50

Plastcare - D915RIT52111 Catalog Number :

Device Description : (2 1/4" x 10") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT73111 Catalog Number :

Device Description : Dental Impression Bite Tray Full Arch (Pink)

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 30

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