FDA.reportPublic FDA data

BRIGHTWATER MEDICAL, INC.

Matched from indexed company URL: BrightWater Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30133760343013376034BRIGHTWATER MEDICAL, INC.1N2020-04-2542580 Rio Nedo Temecula CA US 92590

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
00851571007376ConvertX™ Nephroureteral Stent System - 8.3F - 10.3F Taper x 26cm9512903410xx@xx.xx
00851571007383ConvertX™ Nephroureteral Stent System - 8.3F - 10.3F Taper x 28cm9512903410xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2316291999588746K181669ConvertX Biliary Stent SystemFGE2019-03-14
2316291328074689K161277ConvertX Nephroureteral Stent SystemFAD2016-11-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE12019-03-14
FAD12016-11-22

PMN#

GUDID#