SAGE PRODUCTS, LLC

Address:3909 3 Oaks Rd,CARY,IL,60013,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

CATHETER AND TIP, SUCTION (JOL) (9) Patient personal hygiene kit (NSB) (8) APPLICATOR, ABSORBENT TIPPED, NON-STERILE (KXF) (3) PROTECTOR, DENTAL (BRW) (1)

Premarket Exempt

Yes

Clear

Q-Care - 00618029800923 Catalog Number : 6671

Device Description : Suction Toothbrush with Perox-A-Mint Solution

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : NSB, KXF, JOL

Prescription Use : No

Device Count : 1

Q-Care - 00618029800930 Catalog Number : 6629

Device Description : Q-Care Covered Yankauer and Suction Handle

Device Class : 2

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Toothette Oral Care - 00618029810328 Catalog Number : 4000

Device Description : Disposable Bite Block for Oral Control

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : BRW

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029820976 Catalog Number : 6570

Device Description : Suction Toothbrushes with Perox-A-Mint Solution

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029821003 Catalog Number : 6115

Device Description : Oral Hygiene Kit, Suction Swabs with Antiseptic Oral Rinse and Mouth Moisturizer

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029821058 Catalog Number : 6571

Device Description : Suction Toothbrush with Perox-A-Mint Solution

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : NSB, JOL

Prescription Use : No

Device Count : 1

Q-Care - 00618029821096 Catalog Number : 6673

Device Description : Suction Toothbrush with Antiseptic Oral Rinse

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : KXF, JOL, NSB

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029821102 Catalog Number : 6173

Device Description : Oral Hygiene Kit, Suction Brush with Antiseptic Oral Rinse and Mouth Moisturizer

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : NSB, JOL

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029821157 Catalog Number : 6552

Device Description : Suction Swab System with Perox-A-Mint Solution

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029821164 Catalog Number : 6572

Device Description : Suction Toothbrush with Perox-A-Mint Solution and Mouth Moisturizer

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB, KXF

Prescription Use : No

Device Count : 1

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