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 - 00714646000316 Catalog Number : SVRT-7450-A

Device Description : SecureVac Cushion 100CM X 100CM, 50L Fill

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Pelvis Belly Plus System - 00714646000323 Catalog Number : 5105-00-03

Device Description : Pelvis Belly Pad Set

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Pelvis Belly Large Abdominal Insert - 00714646000330 Catalog Number : PPRT-5106

Device Description : Pelvis Belly, Large Stomach Cushion

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SecureFoam™ Small - 00714646000347 Catalog Number : BKRT-5036

Device Description : SecureFoam, Small, Component A

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

SecureFoam™ Small - 00714646000354 Catalog Number : BKRT-5036

Device Description : SecureFoam, Small, Component B

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

SecureFoam™ Medium - 00714646000378 Catalog Number : BKRT-5037

Device Description : SecureFoam, Medium, Component A

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

SecureFoam™ Medium - 00714646000385 Catalog Number : BKRT-5037

Device Description : SecureFoam. Medium, Component B

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 10

SecureFoam™ Large - 00714646000392 Catalog Number : BKRT-5038

Device Description : SecureFoam, Large, Component A

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 4

SecureFoam™ Large - 00714646000408 Catalog Number : BKRT-5038

Device Description : SecureFoam, Large, Component B

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 4

TruGuard™ - 00714646000415 Catalog Number : HNRT-3501

Device Description : TruGuard, Standard

Device Class : 2

Duns Number: 117844489

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 25

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