BIOCOMPATIBLES UK LTD

Address:KEELE SCIENCE PARK,Keele Staffordshire,GB

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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

Microspheres Radionuclide (NAW) (10)

Premarket Exempt

No Yes

Clear

TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial) - 05060116921489 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 8.5 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial) - 05060116921496 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 9.0 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial) - 05060116921502 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 9.5 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial) - 05060116921519 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 10.0 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial) - 05060116921526 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 10.5 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial) - 05060116921533 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 11.0 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial) - 05060116921540 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 11.5 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial) - 05060116921557 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 12.0 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 12.5 GBq (US Commercial) - 05060116921564 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 12.5 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 13.0 GBq (US Commercial) - 05060116921571 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 13.0 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

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