BIONIX DEVELOPMENT CORPORATION

BIONIX DEVELOPMENT CORPORATION

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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

TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (3) APPLICATOR, ENT DRUG (LRD) (2) SPECULUM, ENT (EPY) (2) SYRINGE, ENT (KCP) (2) BASIN, EMESIS (FNY) (1)

Premarket Exempt

No Yes

Clear

Bionix Development Corporation - 00859911004146 Catalog Number : 7280

Device Description : Ear Lavage System

Device Class : 1

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : LRD

Prescription Use : Yes

Device Count : 1

Bionix Development Corporation - 00859911004153 Catalog Number : 7290

Device Description : SprayWash Kit

Device Class : 1

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : LRD

Prescription Use : Yes

Device Count : 1

Bionix Development Corporation - 00859911004160 Catalog Number : 7200

Device Description : Box of 40 OtoClear Tips

Device Class :

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : KCP

Prescription Use : Yes

Device Count : 40

Bionix Development Corporation - 00859911004184 Catalog Number : 3700

Device Description : Box of 3 Ear Basins

Device Class :

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : FNY

Prescription Use : Yes

Device Count : 3

Bionix Development Corporation - 00859911004191 Catalog Number : 9877

Device Description : Disposable Speculum-48 count

Device Class :

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : Yes

Device Count : 48

Bionix Development Corporation - 00859911004207 Catalog Number : 9878

Device Description : Disposable Speculum-20 count

Device Class :

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : Yes

Device Count : 20

Bionix Development Corporation - 00859911004214 Catalog Number : 17202

Device Description : Box of 20 OtoClear Tips

Device Class :

Duns Number: 602736795

Premarket Exempt : Yes

Product Code : KCP

Prescription Use : Yes

Device Count : 20

BIONIX DEVELOPMENT CORPORATION - 00859911004306 Catalog Number : 911

Device Description : Sample-DeClogger 14-16 F/Blue

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 00859911004313 Catalog Number : 912

Device Description : Sample-DeClogger 16-18 F/Yellow

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 00859911004320 Catalog Number : 913

Device Description : Sample- DeClogger 20-22 F/Green

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

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