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) (10)

Premarket Exempt

Yes No

Clear

White FlexLoop® - 00859911004481 Catalog Number : 9555

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

Safe Ear Curette™ Variety Kit - 00859911004498 Catalog Number : 5777

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 : 75

Lighted Articulating Ear Curette™ - 00859911004511 Catalog Number : 2511

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 25

Lighted AngleLoop® - 00859911004528 Catalog Number : 2210

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Lighted MicroLoop® - 00859911004535 Catalog Number : 2220

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Lighted WaveCurette™ - 00859911004542 Catalog Number : 2230

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Lighted FlexLoop® - 00859911004559 Catalog Number : 2240

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Lighted Ear Curette™ Variety Pack - 00859911004566 Catalog Number : 2245

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Lighted CeraSpoon® - 00859911004573 Catalog Number : 2250

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

Lighted InfantScoop® - 00859911004580 Catalog Number : 2260

Device Description : Lighted curette for cerumen removal

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : Yes

Device Count : 50

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