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

Device, Neurovascular Embolization (HCG) (6) Device, Vascular, For Promoting Embolization (KRD) (6) Microspheres Radionuclide (NAW) (4) Agents, Embolic, For Treatment Of Uterine Fibroids (NAJ) (2)

Premarket Exempt

No Yes

Clear

Bead Block 100-300 - 05060116920055 Catalog Number :

Device Description : Embolization spheres

Device Class : 2

Duns Number: 222870839

Premarket Exempt : No

Product Code : HCG, KRD

Prescription Use : Yes

Device Count : 1

Bead Block 300-500 - 05060116920062 Catalog Number :

Device Description : Embolization spheres

Device Class : 2

Duns Number: 222870839

Premarket Exempt : No

Product Code : HCG, KRD

Prescription Use : Yes

Device Count : 1

Bead Block 500-700 - 05060116920079 Catalog Number :

Device Description : Embolic spheres.

Device Class : 2

Duns Number: 222870839

Premarket Exempt : No

Product Code : HCG, KRD

Prescription Use : Yes

Device Count : 1

Bead Block 700-900 - 05060116920086 Catalog Number :

Device Description : Embolic spheres

Device Class : 2

Duns Number: 222870839

Premarket Exempt : No

Product Code : HCG, KRD, NAJ

Prescription Use : Yes

Device Count : 1

Bead Block 900-1200 - 05060116920093 Catalog Number :

Device Description : Embolic spheres

Device Class : 2

Duns Number: 222870839

Premarket Exempt : No

Product Code : HCG, KRD, NAJ

Prescription Use : Yes

Device Count : 1

LC Bead 500-700 - 05060116920208 Catalog Number :

Device Description : Embolic spheres

Device Class : 2

Duns Number: 222870839

Premarket Exempt : No

Product Code : HCG, KRD

Prescription Use : Yes

Device Count : 1

TheraSphere Administration Accessory Kit - 05060116920246 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

TheraSphere Administration Set - 05060116920253 Catalog Number :

Device Description : Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres

Device Class :

Duns Number: 222870839

Premarket Exempt : No

Product Code : NAW

Prescription Use : Yes

Device Count : 1

TheraSphere Y90 Glass Microspheres 3 GBq - 05060116920284 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 3 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 GBq - 05060116920291 Catalog Number :

Device Description : TheraSphere Yttrium-90 Glass Microspheres 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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