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

Accelerator, linear, medical (IYE) (4) UTENSIL, EATING (ILC) (4) MARKER, SKIN (FZZ) (2)

Premarket Exempt

No Yes

Clear

Bionix, LLC - 00714646000002 Catalog Number : 23100

Device Description : Sample: 18g Accu-Tatt®

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : Yes

Device Count : 1

Bionix, LLC - 00714646000019 Catalog Number : 23105

Device Description : Sample: 22g Accu-Tatt®

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : FZZ

Prescription Use : Yes

Device Count : 1

SecureFoam™ Pouch-Pro® - 00714646000026 Catalog Number : BKRT-5040

Device Description : SecureFoam Pouch-Pro 5/box

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 5

SafeStraw™ NeoTarget Co-brand - 00714646000057 Catalog Number : 203

Device Description : SafeStraw, White, NeoTarget Co-brand

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : Yes

Device Count : 1

SafeStraw™ NeoTarget Co-brand - 00714646000064 Catalog Number : 204

Device Description : SafeStraw, White, NeoTarget Co-brand (simplified)

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : Yes

Device Count : 1

SafeStraw™ NeoTarget Co-brand - 00714646000071 Catalog Number : 213

Device Description : SafeStraw, Blue, NeoTarget Co-brand

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : Yes

Device Count : 1

SafeStraw™ NeoTarget Co-brand - 00714646000088 Catalog Number : 214

Device Description : SafeStraw, Blue, NeoTarget Co-brand (simplified)

Device Class : 1

Duns Number: 117844489

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000170 Catalog Number : SVRT-7130

Device Description : SecureVac Cushion 150CM X 70CM, 55L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000187 Catalog Number : SVRT-7131

Device Description : SecureVac Cushion 80CM X 150CM, 35L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000194 Catalog Number : SVRT-7132

Device Description : SecureVac Cushion 80CM X 150CM, 47L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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