BIOCOMPATIBLES UK LTD

Address:KEELE SCIENCE PARK,Keele Staffordshire,GB

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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

Microspheres Radionuclide (NAW) (10)

Premarket Exempt

No Yes

Clear

TheraSphere Y90 Glass Microspheres 7 GBq - 05060116920307 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 7 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 10 GBq - 05060116920314 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 10 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 15 GBq - 05060116920321 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 15 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 20 GBq - 05060116920338 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 20 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 3.5 GBq - 05060116920345 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 3.5 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 4.0 GBq - 05060116920352 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 4.0 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 4.5 GBq - 05060116920369 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 4.5 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 5.5 GBq - 05060116920376 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 5.5 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 6.0 GBq - 05060116920383 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 6.0 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 6.5 GBq - 05060116920390 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 6.5 GBq Dose

Device Class : 3

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

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