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) (5)

Premarket Exempt

No Yes

Clear

TheraSphere Y90 Glass Microspheres 18.5 GBq (US Commercial) - 05060116921687 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 18.5 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 19.0 GBq (US Commercial) - 05060116921694 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 19.0 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 19.5 GBq (US Commercial) - 05060116921700 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 19.5 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 20.0 GBq (US Commercial) - 05060116921717 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 20.0 GBq Dose (US Commercial)

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Administration Accessory Kit (US) - 05060116922073 Catalog Number :

Device Description : For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glas For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microspheres

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

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