Bionix, LLC

Address:1670 Indianwood Circle,Maumee,OH,43537,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

CURETTE, EAR (JYG) (6) SYRINGE, ENT (KCP) (2) UTENSIL, EATING (ILC) (2)

Premarket Exempt

Yes No

Clear

SafeStraw™ Drinking Aid for Thin Liquid - 00859911004085 Catalog Number : 202

Device Description : SafeStraw. White, Thin Liquid

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : No

Device Count : 12

SafeStraw™ Drinking Aid for Thick Liquid - 00859911004092 Catalog Number : 212

Device Description : SafeStraw, Blue, Thick Liquid

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : No

Device Count : 12

OtoClear® WaterPik® Kit - 00859911004177 Catalog Number : 7245

Device Description : Portable WaterPik

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : KCP

Prescription Use : Yes

Device Count : 1

OtoClear® Spray Wash Kit - 00859911004290 Catalog Number : 7295

Device Description : SprayWash Bottle

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : KCP

Prescription Use : Yes

Device Count : 1

Green MicroLoop® - 00859911004429 Catalog Number : 1222

Device Description : Curette used for safe cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Orange ControLoop® - 00859911004436 Catalog Number : 2999

Device Description : Curette used for safe cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Red AngleLoop® - 00859911004443 Catalog Number : 3444

Device Description : Curette used for safe cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Purple VersaLoop® - 00859911004450 Catalog Number : 4111

Device Description : Curette used for safe cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Blue InfantScoop® - 00859911004467 Catalog Number : 4888

Device Description : Curette used for safe cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Yellow CeraSpoon® - 00859911004474 Catalog Number : 6333

Device Description : Curette used for safe cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

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