| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002124543 | 3002124543 | BIOCOMPATIBLES U.K. LIMITED, a BTG Company | 1 | N | 2026-01-01 | Chapman House, Weydon Lane Farnham Business Park Farnham, SURREY ENGLAND GB GU9 8QL |
| 1225114 | 3012516557 | Biocompatibles Inc., a BTG Company | 1 | Y | 2020-04-25 | 300 Four Falls Corporate Center #300 300 Conshohocken State Road W Cnshohocken PA US 19428 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05060116920253 | TheraSphere Administration Set - Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres | 1-866-363-3330 | TheraSphereCustomerSupport@btgplc.com |
| 05060116921663 | TheraSphere Y90 Glass Microspheres 17.5 GBq (US Commercial) - TheraSphere Yttrium-90 Glass Microspheres 17.5 GBq Dose (US Commercial) | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| 05060116921670 | TheraSphere Y90 Glass Microspheres 18.0 GBq (US Commercial) - TheraSphere Yttrium-90 Glass Microspheres 18.0 GBq Dose (US Commercial) | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| 05060116921687 | TheraSphere Y90 Glass Microspheres 18.5 GBq (US Commercial) - TheraSphere Yttrium-90 Glass Microspheres 18.5 GBq Dose (US Commercial) | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| 05060116921694 | TheraSphere Y90 Glass Microspheres 19.0 GBq (US Commercial) - TheraSphere Yttrium-90 Glass Microspheres 19.0 GBq Dose (US Commercial) | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| 05060116921700 | TheraSphere Y90 Glass Microspheres 19.5 GBq (US Commercial) - TheraSphere Yttrium-90 Glass Microspheres 19.5 GBq Dose (US Commercial) | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| 05060116921717 | TheraSphere Y90 Glass Microspheres 20.0 GBq (US Commercial) - TheraSphere Yttrium-90 Glass Microspheres 20.0 GBq Dose (US Commercial) | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| 05060116922073 | TheraSphere Administration Accessory Kit (US) - For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microspheres | 1-866-363-3330 | TheraSphereCustomerSupport@bsci.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 233878 | 1414172803 | P200029 | TheraSphere | NAW | 2021-03-17 |
| 233878 | 1689254142 | K162373 | LC Bead LUMI | KRD | 2016-12-16 |
| 233878 | 1474892832 | K152157 | LC Bead LUMI | KRD | 2015-12-11 |
| 233878 | 1362641604 | K150876 | Bead Block | KRD | 2016-03-07 |
| 233878 | 1417812736 | K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | HCG | 2010-04-16 |
| 233878 | 1916396269 | K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | KRD | 2008-12-24 |
| 233878 | 1081263507 | H980006 | |||
| 233878 | 1021037186 | ||||
| 233878 | 1158521977 | ||||
| 233878 | 1271373896 | ||||
| 233878 | 2020619580 |
Biocompatibles UK Ltd (Part of Boston Scientific Corporation
Biocompatibles UK Limited
BIOCOMPATIBLES UK LTD
BIOCOMPATIBLES UK LTD
BIOCOMPATIBLES INC.
BIOCOMPATIBLES, INC.
BIOCOMPATIBLES U.K. LIMITED
BIOCOMPATIBLES, INC.
BIOCOMPATIBLES U.K. LIMITED
BIOCOMPATIBLES U.K. LIMITED
BIOCOMPATIBLES U.K. LIMITED
BIOCOMPATIBLES EYEWEAR, INC.
BIOCOMPATIBLES EYEWEAR, INC.
BIOCOMPATIBLES CARDIOVASCULAR, INC.
BIOCOMPATIBLES EYEWEAR, INC.
BIOCOMPATIBLES CARDIOVASCULAR, INC.
BIOCOMPATIBLES CARDIOVASCULAR, INC.
BIOCOMPATIBLES LTD.
BIOCOMPATIBLES LTD.
BIOCOMPATIBLES LTD.
2014-09-24
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2016-08-11
2016-08-11
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