FDA.reportPublic FDA data

BIOCOMPATIBLES U.K. LIMITED, a BTG Company

Matched from indexed company URL: BIOCOMPATIBLES INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30021245433002124543BIOCOMPATIBLES U.K. LIMITED, a BTG Company1N2026-01-01Chapman House, Weydon Lane Farnham Business Park Farnham, SURREY ENGLAND GB GU9 8QL
12251143012516557Biocompatibles Inc., a BTG Company1Y2020-04-25300 Four Falls Corporate Center #300 300 Conshohocken State Road W Cnshohocken PA US 19428

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05060116920581TheraSphere Y90 Glass Microspheres 17.5 GBq - TheraSphere Yttrium-90 Glass Microspheres 17.5 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btg
05060116920581TheraSphere Y90 Glass Microspheres 17.5 GBq - TheraSphere Yttrium-90 Glass Microspheres 17.5 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btgplc.com
05060116920598TheraSphere Y90 Glass Microspheres 18.0 GBq - TheraSphere Yttrium-90 Glass Microspheres 18.0 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btg
05060116920598TheraSphere Y90 Glass Microspheres 18.0 GBq - TheraSphere Yttrium-90 Glass Microspheres 18.0 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btgplc.com
05060116920604TheraSphere Y90 Glass Microspheres 18.5 GBq - TheraSphere Yttrium-90 Glass Microspheres 18.5 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btg
05060116920604TheraSphere Y90 Glass Microspheres 18.5 GBq - TheraSphere Yttrium-90 Glass Microspheres 18.5 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btgplc.com
05060116920611TheraSphere Y90 Glass Microspheres 19.0 GBq - TheraSphere Yttrium-90 Glass Microspheres 19.0 GBq Dose1-866-363-3330TheraSphereCustomerSupport@btg

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2338781414172803P200029TheraSphereNAW2021-03-17
2338781689254142K162373LC Bead LUMIKRD2016-12-16
2338781474892832K152157LC Bead LUMIKRD2015-12-11
2338781362641604K150876Bead BlockKRD2016-03-07
2338781417812736K094018LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERESHCG2010-04-16
2338781916396269K083091LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERESKRD2008-12-24
2338781081263507H980006
2338781021037186
2338781158521977
2338781271373896
2338782020619580

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRD42016-12-16
NAW 12021-03-17
HCG12010-04-16

PMN#

GUDID#

Varithena® Administration Pack - The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer Tube and 2 Compression pads) . The administration pack is not subject to a 510K as each of the components has clearance as a medical device via a 510K (Syringe and Manometer Tubing) or 510K exempt devices (Compression Pads, Varithena Transfer Unit). The Varithena® administration pack is provided with the Varithena® drug product pack to the customer.

BIOCOMPATIBLES UK LTD

2016-09-24

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