FDA.reportPublic FDA data

GENTELL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25309571000522686GENTELL1Y2026-01-01180 Rittenhouse Circle Bristol PA US 19007

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
911661347960143K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)FRO2024-10-07
911661621964692K231152Collagen Wound DressingKGN2023-10-12
911661503075005K213598LUOFUCON Collagen Wound DressingKGN2022-09-20
911662033871075K122325SKINTEMP IIKGN2012-10-26
911661718824218K120181LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMFRO2013-02-14
911661462752994K110042MANUKATEXFRO2011-03-24
911661617863750K102659MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDERFRO2010-12-08
911661099984419K092689MANUKAPLI WOUND DRESSINGFRO2010-05-20
911661323757562
911661599333356
911661210853084
911661256717249
911661450747080
911661531004521
911661720085320
911661790413839
911661828699463
911661848443483
911661962044422
911662008600296
911662061252151
911662067995890
911662072307250

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO52024-10-07
KGN32023-10-12

PMN#