Harry J Bosworth Company

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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

RESIN, DENTURE, RELINING, REPAIRING, REBASING (EBI) (10)

Premarket Exempt

No Yes

Clear

Bosworth New Truliner - H66809219741 Catalog Number : 0921974

Device Description : 8 oz New Truliner PEMA Pwd Vein

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219751 Catalog Number : 0921975

Device Description : 8 oz New Truliner PEMA Pwd Clear

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219761 Catalog Number : 0921976

Device Description : New Truliner Liquid

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219771 Catalog Number : 0921977

Device Description : New Truliner 1 lb bulk PEMA P&L Kit Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219781 Catalog Number : 0921978

Device Description : New Truliner 1 lb bulk PEMA P&L Kit Vein

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219801 Catalog Number : 0921980

Device Description : 1 lb New Truliner PEMA Pwd Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219831 Catalog Number : 0921983

Device Description : 1/3 oz Bonding Liquid

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219841 Catalog Number : 0921984

Device Description : 4 oz Bonding Liquid

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H66809219851 Catalog Number : 0921985

Device Description : New Truliner PEMA 3 oz P & 1 oz L Mini Kit Pink

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

Bosworth New Truliner - H6680921985C1 Catalog Number : 0921985C

Device Description : New Truliner PEMA 3 oz P & 1 oz L Mini Kit Clear

Device Class : 2

Duns Number: 014769301

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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