FDA.reportPublic FDA data

Rachael Nelsen

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049113843004911384Rachael Nelsen1N2027-01-014142 Industry Way, Flowery Br GA US 30542
30149253893014925389Rachael Nelsen1N2027-01-014142 Industry Way Flowery Br GA US 30542
30149253933014925393Rachael Nelsen1N2027-01-014142 Industry Way Flowery Branch GA US 30542

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2961431105711549K913682MERIT CUSTOM KITDQO1991-11-15
2961432030671818K851090MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEEFMF1985-04-12
2229171120558998K250082Procedure mask/Surgical mask/Face maskFXX2025-06-18
2961431233574084K242664gentleheel® Adult Incision DeviceFMK2024-11-05
2961431840512753K220917gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerFMK2022-05-18
2961431026876782K172445RoyalGuard Surgical Gown, i600, BreathableFYA2017-12-08
2229171751255123K172445RoyalGuard Surgical Gown, i600, BreathableFYA2017-12-08
2229171839060283K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500FYA2016-12-12
2961432005223115K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500FYA2016-12-12
2961431975265828K111282DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLESFLL2011-08-11
2961431136838068K103830JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)FMF2011-07-29
2961431261906802K102652NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNSFYA2011-02-03
2229171863889480K102652NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNSFYA2011-02-03
2961431789888053K092634OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DFGEI2009-12-01
2229171055172753
2229171093141220
2229171176002214
2229171216549222
2229171339591473
2229171390390098
2229171391931183
2229171522819763
2229171631000891
2229171702626484
2229171748674067
2229171753366316
2229171855027903
2229171906344227
2229171942455353
2961431027103448
2961431027589342
2961431031232955
2961431036820321
2229171050079558
3316711050079558
2961431050773766
2961431051686701
2961431104106248
2961431106726286
2961431130532882
2961431149083067
2961431162853332
2961431185542915
2961431191520512
2961431215297682
2961431222647531
2229171228232291
3316711228232291
2961431253484156
2961431253582272
2961431256815548
2229171264441385
2961431270097248
2961431279175581
2961431296752396
2229171315160215
2961431318091954
2961431347915313
2961431360716376
2961431365605050
2961431381874787
2961431403394295
2229171440452031
2961431466936834
2229171484511277
2961431502148478
2229171520147629
2961431522500535
2961431523455903
2961431536048710
2961431536695220
2229171539468042
2961431560119381
2961431570929689
2229171585219442
2961431605783013
2961431610159133
2961431610295637
2961431640003620
2961431678589554
2961431685227102
2961431717578621
2961431741095828
2961431741446988
2961431751741443
2961431756729549
2229171764637291
2961431765742199
2961431773522488
2961431774762316
2961431799922339
2961431804919231
2961431821566682
2961431823198575
2961431823791586
2229171839060283
3316711839060283
2961431849464977
2229171863889480
3316711863889480
2961431869449378
2961431875165301
2961431878322693
2961431894201699
2961431902346358
2961431905676357

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FYA72017-12-08
FMK22024-11-05
FMF22011-07-29
FXX12025-06-18
FLL12011-08-11
GEI12009-12-01
DQO11991-11-15