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) (10)

Premarket Exempt

No Yes

Clear

SecureVac™ Immobilization System - 00714646000200 Catalog Number : SVRT-7133

Device Description : SecureVac Cushion 80CM X 150CM, 55L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000217 Catalog Number : SVRT-7134

Device Description : SecureVac Cushion 80CM X 150CM, 70L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000224 Catalog Number : SVRT-7380

Device Description : SecureVac Cushion 150CM X 100CM, 80L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000231 Catalog Number : SVRT-7535-A

Device Description : SecureVac Cushion 100CM X 70CM, 35L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000248 Catalog Number : SVRT-7600

Device Description : SecureVac Cushion, TriVac

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000255 Catalog Number : SVRT-7625

Device Description : SecureVac Cushion, T-Vac

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000262 Catalog Number : SVRT-7630

Device Description : SecureVac Cushion 115CM X 114CM, 25L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000279 Catalog Number : SVRT-7635

Device Description : SecureVac Cushion 115CM X 114CM, 35L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000286 Catalog Number : SVRT-7820-A

Device Description : SecureVac Cushion 70CM X 70CM, 20L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureVac™ Immobilization System - 00714646000293 Catalog Number : SVRT-7915

Device Description : SecureVac Cushion 70CM X 50CM, 15L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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