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

APPLICATOR, ABSORBENT TIPPED, NON-STERILE (KXF) (10) CATHETER AND TIP, SUCTION (JOL) (10) Patient personal hygiene kit (NSB) (10)

Premarket Exempt

Yes

Clear

Toothette Oral Care - 00618029821171 Catalog Number : 6576

Device Description : Untreated Suction Toothbrush, Suction Swab, and Applicator Swab

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, KXF, NSB

Prescription Use : No

Device Count : 1

Toothette Oral Care - 00618029821331 Catalog Number : 6592

Device Description : Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : KXF, JOL, NSB

Prescription Use : Yes

Device Count : 1

Toothette Oral Care - 00618029821348 Catalog Number : 6594

Device Description : Q4 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, KXF, NSB

Prescription Use : Yes

Device Count : 1

Sage - 00618029821515 Catalog Number : 6145

Device Description : Suction Swab with Corinz

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB, KXF

Prescription Use : No

Device Count : 1

Sage - 00618029821522 Catalog Number : 6561

Device Description : Suction Toothbrush with Corinz

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : KXF, NSB, JOL

Prescription Use : No

Device Count : 1

Q-Care - 00618029830081 Catalog Number : 6904

Device Description : Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluco Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, KXF, NSB

Prescription Use : Yes

Device Count : 1

Q-Care - 00618029830166 Catalog Number : 6912

Device Description : Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluco Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : NSB, JOL, KXF

Prescription Use : Yes

Device Count : 1

Q-Care - 00618029830173 Catalog Number : 6914

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB, KXF

Prescription Use : Yes

Device Count : 1

Q-Care Rx - 00618029830258 Catalog Number : 9002

Device Description : Q-Care Rx Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate Q-Care Rx Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : NSB, JOL, KXF

Prescription Use : Yes

Device Count : 1

Q-Care - 00618029830272 Catalog Number : 6424

Device Description : Q-Care, Q4, Oral Cleansing & Suctioning System

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : KXF, NSB, JOL

Prescription Use : Yes

Device Count : 1

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