FDA.reportPublic FDA data

Reynaldo Librojo

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037026463003702646Reynaldo Librojo1N2026-01-011000 Us Highway 202 Raritan NJ US 08869
30049035803004903580Reynaldo Librojo1N2026-01-011000 Us Highway 202 Raritan NJ US 08869
30136444993013644499Reynaldo Librojo1N2026-01-011000 US Highway 202 S. Raritan NJ US 08869
30142727343014272734Reynaldo Librojo1N2026-01-011000 US Highway 202 Raritan NJ US 08869

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2264001374147974P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USPLMF1999-09-30
855971170950481P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIERMCN1989-09-15
2264001008974184P240035ETHIZIASGV2025-12-15
855971473257636N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG1960-10-14
2264001501322808K991999STERRAD 100S STERILIZERMLR2000-06-15
2264001211150246K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
2264001526808470K981625STERRAD 50 STERILIZERMLR1999-01-11
3340111063365647K843187CANNULAGEA1984-10-31
2264001114177848K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC2026-01-09
2264001886056353K221343ECHELON ENDOPATH Staple Line ReinforcementOXC2022-09-16
2264001771248822K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged GuideOTN2020-09-17
2264001422825089K190937Echelon Endopath Staple Line ReinforcementOXC2019-10-14
2264002024215446K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureGAM2019-06-27
2264001085523328K181744BI-MENTUM dual mobility systemLZO2018-12-11
2264001530004738K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemPWJ2018-08-10
2264001475918027K180910ULTRAPRO Mesh and ULTRAPRO ADVANCEDFTL2018-07-02
2264001461340455K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTDQK2018-06-01
2264001653168984K173162GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter GuidePWJ2018-06-28
2264001790870716K173019GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System TrocarPWJ2018-07-06
2264001084781215K172054Materialise Glenoid Positioning SystemKWS2017-11-03
2264001818605693K141560ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICEFTL2014-10-23
2264001512297380K140318SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETEROBJ2014-03-12
2264001455404624K133198ULTRAPRO COMFORT PLUGFTL2014-05-30
2264001512793940K132054GYNECARE TVT EXACT CONTINENCE SYSTEMOTN2013-08-23
2264001860854290K113205ARTISYN Y-SHAPED MESHOTO2012-06-11
2264001113272318K112050SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETEROBJ2011-11-18
2264001936972160K100936GYNECARE TVT ABBREVO CONTINENCE SYSTEMOTN2010-07-01
2264001212655891K092064SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12OBJ2009-08-07
2264001853946636K071385STERRAD 100NX STERILIZERMLR2007-11-29
2264001818133247K071249ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOVFTL2007-06-05
2264001328009433K071234ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10FOBJ2007-06-29
2264001005028630K070224ULTRAPRO PLUGFTL2007-04-17
2264001454780297K061533PROCEED VENTRAL PATCHFTL2006-12-11
2264001526217743K051701VICRYL * MESH BAGFTL2005-09-29
2264001693917034K042116STERRAD NX STERILIZERMLR2005-04-22
3340111943328235K033746MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTUREGAM2003-12-18
2264001337302736K033568GYNECARE TVT OBTURATOR SYSTEMOTN2003-12-08
2264001709264200K012628GYNECARE TENSION-FREE VAGINAL TAPE SYSTEMOTN2001-10-26
855971909989521
643951100319313
3340111289244727
855971337302736
855971512793940
855971530004738
855971653168984
643951680405933
855971709264200
855971771248822
855971790870716
855971936972160
643951970077295
643952016001617

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OTN92020-09-17
FTL72018-07-02
PWJ42018-08-10
OBJ42014-03-12
MLR42007-11-29
OXC32026-01-09
GAM22019-06-27
LZO12018-12-11
DQK12018-06-01
KWS12017-11-03
OTO12012-06-11
LMF11999-09-30
DYB11998-08-28
MCN11989-09-15
GEA11984-10-31
LMG11960-10-14