Reprocessed DECANAV? Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
Sterilmed, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011276773 | 3011276773 | STERILMED, INC. | 1 | N | 2026-01-01 | 5010 Cheshire Pkwy N Ste 2 Plymouth MN US 55446 |
| 2134070 | 3001237663 | STERILMED, INC. | 1 | N | 2020-04-25 | 11400 73rd Ave N Ste 100 MAPLE GROVE MN US 55369 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10888551001205 | NA - CABLE SURGICAL W/SMALL ALLIGATOR CLIPS | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551004312 | NA - BUR FLUTED BALL LEGEND SYSTEM | +1(888)541-0078 | customerservice@sterilmed.com |
| 10888551004312 | NA - BUR FLUTED BALL LEGEND SYSTEM | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551004329 | NA - BUR DIAMOND BALL LEGEND SYSTEM | +1(888)541-0078 | customerservice@sterilmed.com |
| 10888551004329 | NA - BUR DIAMOND BALL LEGEND SYSTEM | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551017862 | NA - BUR CEBOTOME ROUND | +1(888)541-0078 | customerservice@sterilmed.com |
| 10888551017862 | NA - BUR CEBOTOME ROUND | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551045735 | Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on GE System - Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551045742 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE System - Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551045759 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on Siemens System - Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| 10888551045766 | Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on Siemens System - Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System | +1(888)541-0078 | sterilmedcs@its.jnj.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 177649 | 1423256152 | K254149 | Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | OWQ | 2026-06-29 |
| 177649 | 1535449900 | K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | NLH | 2024-10-11 |
| 177649 | 1665353234 | K231473 | Monarch Bronchoscope | QNW | 2023-11-28 |
| 177649 | 1240541484 | K203614 | Monarch Bronchoscope | QNW | 2021-03-11 |
| 177649 | 1386429361 | K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | MTD | 2021-06-23 |
| 177649 | 1342937575 | K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | 2019-08-15 |
| 17102 | 1342937575 | K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | NLQ | 2019-08-15 |
| 177649 | 1424778931 | K190478 | Reprocessed ViewFlex™ Xtra ICE Catheter | OWQ | 2019-11-14 |
| 17102 | 1424778931 | K190478 | Reprocessed ViewFlex™ Xtra ICE Catheter | OWQ | 2019-11-14 |
| 177649 | 1379522844 | K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | NLQ | 2019-04-15 |
| 17102 | 1379522844 | K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | NLQ | 2019-04-15 |
| 17102 | 1897112521 | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | OWQ | 2016-11-21 |
| 177649 | 1897112521 | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | OWQ | 2016-11-21 |
| 17102 | 1806254045 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | 2016-11-10 |
| 177649 | 1806254045 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | KTT | 2016-11-10 |
| 17102 | 1257581101 | K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | NUJ | 2016-09-20 |
| 177649 | 1257581101 | K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | NUJ | 2016-09-20 |
| 177649 | 1549385925 | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | NLH | 2016-06-23 |
| 17102 | 1549385925 | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | NLH | 2016-06-23 |
| 177649 | 1414888668 | K152134 | Reprocessed Vessel Sealer | NUJ | 2016-01-15 |
| 17102 | 1414888668 | K152134 | Reprocessed Vessel Sealer | NUJ | 2016-01-15 |
| 17102 | 1136591813 | K152090 | Reprocessed Steerable Introducer | PNE | 2016-03-23 |
| 177649 | 1136591813 | K152090 | Reprocessed Steerable Introducer | PNE | 2016-03-23 |
| 177649 | 1433654148 | K150357 | Reprocessed Electrophysiology Diagnostic Catheters | NLH | 2015-08-27 |
| 17102 | 1433654148 | K150357 | Reprocessed Electrophysiology Diagnostic Catheters | NLH | 2015-08-27 |
| 17102 | 1337054734 | K143562 | Reprocessed Cordless Ultrasonic Dissection Device | NLQ | 2015-05-20 |
| 177649 | 1337054734 | K143562 | Reprocessed Cordless Ultrasonic Dissection Device | NLQ | 2015-05-20 |
| 17102 | 1568484681 | K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | NUJ | 2015-02-23 |
| 177649 | 1568484681 | K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | NUJ | 2015-02-23 |
| 177649 | 1902412299 | K133414 | REPROCESSED CLOSURE SYSTEM | NLM | 2014-01-22 |
| 17102 | 1902412299 | K133414 | REPROCESSED CLOSURE SYSTEM | NLM | 2014-01-22 |
| 17102 | 1247098776 | K123096 | REPROCESSED VESSEL SEALER | NUJ | 2013-01-25 |
| 177649 | 1247098776 | K123096 | REPROCESSED VESSEL SEALER | NUJ | 2013-01-25 |
| 177649 | 1800549479 | K121240 | REPROCESSED ENDOSCOPIC TROCARS | NLM | 2012-06-11 |
| 17102 | 1800549479 | K121240 | REPROCESSED ENDOSCOPIC TROCARS | NLM | 2012-06-11 |
| 177649 | 1374549402 | K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2012-08-06 |
| 17102 | 1374549402 | K121158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2012-08-06 |
| 177649 | 1502255887 | K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT | NUJ | 2012-10-05 |
| 17102 | 1502255887 | K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT | NUJ | 2012-10-05 |
| 177649 | 1819357577 | K111794 | REPROCESSED HARMONIC SCALPEL | NLQ | 2012-01-11 |
| 17102 | 1819357577 | K111794 | REPROCESSED HARMONIC SCALPEL | NLQ | 2012-01-11 |
| 177649 | 1062203266 | K111002 | REPROCESSED ENDOSCOPIC TROCARS | NLM | 2011-07-18 |
| 17102 | 1062203266 | K111002 | REPROCESSED ENDOSCOPIC TROCARS | NLM | 2011-07-18 |
| 177649 | 1760064433 | K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER | OWQ | 2011-08-18 |
| 17102 | 1760064433 | K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER | OWQ | 2011-08-18 |
| 177649 | 1070291146 | K102560 | REPROCESSED PULSE OXIMETER SENSORS | NLF | 2011-02-18 |
| 17102 | 1070291146 | K102560 | REPROCESSED PULSE OXIMETER SENSORS | NLF | 2011-02-18 |
| 177649 | 1979881452 | K101789 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2010-08-19 |
| 17102 | 1979881452 | K101789 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2010-08-19 |
| 177649 | 1462389594 | K100707 | REPROCESSED PINS | NDM | 2010-06-25 |
| 17102 | 1462389594 | K100707 | REPROCESSED PINS | NDM | 2010-06-25 |
| 177649 | 1902398136 | K092368 | REPROCESSED PULSE OXIMETER SENSORS | NLF | 2009-11-03 |
| 17102 | 1902398136 | K092368 | REPROCESSED PULSE OXIMETER SENSORS | NLF | 2009-11-03 |
| 177649 | 1627923304 | K092158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2010-01-14 |
| 17102 | 1627923304 | K092158 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2010-01-14 |
| 177649 | 1707634599 | K083636 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | 2009-03-02 |
| 17102 | 1707634599 | K083636 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | 2009-03-02 |
| 177649 | 1357107724 | K083060 | REPROCESSED HARMONIC SCALPEL | NLQ | 2009-01-09 |
| 17102 | 1357107724 | K083060 | REPROCESSED HARMONIC SCALPEL | NLQ | 2009-01-09 |
| 177649 | 1430969042 | K081814 | REPROCESSED ENT SHAVERS | ERL | 2008-12-17 |
| 17102 | 1430969042 | K081814 | REPROCESSED ENT SHAVERS | ERL | 2008-12-17 |
| 17102 | 1223137970 | K081586 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | 2008-08-18 |
| 177649 | 1223137970 | K081586 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | 2008-08-18 |
| 177649 | 2010620653 | K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES | KTT | 2008-08-13 |
| 17102 | 2010620653 | K081342 | REPROCESSED EXTERNAL FIXATION ACCESSORIES | KTT | 2008-08-13 |
| 177649 | 1881825873 | K073613 | REPROCESSED SCISSOR TIPS | NUJ | 2008-02-12 |
| 17102 | 1881825873 | K073613 | REPROCESSED SCISSOR TIPS | NUJ | 2008-02-12 |
| 17102 | 1137331620 | K052299 | REPROCESSED ENDOSCOPIC TROCAR | NLM | 2006-05-23 |
| 177649 | 1137331620 | K052299 | REPROCESSED ENDOSCOPIC TROCAR | NLM | 2006-05-23 |
| 177649 | 1819376348 | K051957 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | 2005-09-21 |
| 17102 | 1819376348 | K051957 | REPROCESSED EXTERNAL FIXATION DEVICE | KTT | 2005-09-21 |
| 177649 | 1713852176 | K051220 | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2005-06-14 |
| 17102 | 1713852176 | K051220 | REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2005-06-14 |
| 177649 | 1148991881 | K050343 | REPROCESSED HARMONIC SCALPELS | NLQ | 2005-04-12 |
| 17102 | 1148991881 | K050343 | REPROCESSED HARMONIC SCALPELS | NLQ | 2005-04-12 |
| 177649 | 1256528510 | K050136 | REPROCESSED HOT BIOPSY FORCEPS | NLU | 2005-07-20 |
| 17102 | 1256528510 | K050136 | REPROCESSED HOT BIOPSY FORCEPS | NLU | 2005-07-20 |
| 17102 | 1969471443 | K043592 | REPROCESSED ENDOSCOPIC TROCAR | NLM | 2005-05-23 |
| 177649 | 1969471443 | K043592 | REPROCESSED ENDOSCOPIC TROCAR | NLM | 2005-05-23 |
| 177649 | 1150075065 | K043513 | STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER | NLH | 2005-03-01 |
| 17102 | 1150075065 | K043513 | STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER | NLH | 2005-03-01 |
| 177649 | 1920413492 | K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER | OWQ | 2005-03-01 |
| 17102 | 1920413492 | K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER | OWQ | 2005-03-01 |
| 177649 | 1770475544 | K042648 | REPROCESSED COLD BIOPSY FORCEPS | NON | 2005-07-20 |
| 17102 | 1770475544 | K042648 | REPROCESSED COLD BIOPSY FORCEPS | NON | 2005-07-20 |
| 17102 | 1389728823 | K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | NLF | 2004-09-23 |
| 177649 | 1389728823 | K041127 | MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS | NLF | 2004-09-23 |
| 177649 | 1890399433 | K033579 | REPROCESSED MULTIPLE CLIP APPLIERS | NMJ | 2005-07-11 |
| 17102 | 1890399433 | K033579 | REPROCESSED MULTIPLE CLIP APPLIERS | NMJ | 2005-07-11 |
| 177649 | 1996665652 | K012679 | REPROCESSED RF ARTHROSCOPY PROBES | GEI | 2001-11-08 |
| 17102 | 1996665652 | K012679 | REPROCESSED RF ARTHROSCOPY PROBES | GEI | 2001-11-08 |
| 17102 | 1862838063 | K012678 | REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2002-08-14 |
| 177649 | 1862838063 | K012678 | REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2002-08-14 |
| 177649 | 1360474652 | K012677 | REPROCESSED PULSE OXIMETER SENSORS | NLF | 2003-03-28 |
| 17102 | 1360474652 | K012677 | REPROCESSED PULSE OXIMETER SENSORS | NLF | 2003-03-28 |
| 177649 | 1423113944 | K012598 | REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS | NUJ | 2001-11-07 |
| 17102 | 1423113944 | K012598 | REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS | NUJ | 2001-11-07 |
| 17102 | 1611768117 | K012597 | STERILMED REPROCESSED COMPRESSION SLEEVES | JOW | 2002-02-11 |
| 177649 | 1611768117 | K012597 | STERILMED REPROCESSED COMPRESSION SLEEVES | JOW | 2002-02-11 |
| 177649 | 1221759936 | K012578 | REPROCESSED ENDOSCOPIC TROCAR | NLM | 2001-11-07 |
| 17102 | 1221759936 | K012578 | REPROCESSED ENDOSCOPIC TROCAR | NLM | 2001-11-07 |
| 17102 | 1585198105 | K012571 | REPROCESSED HARMONIC | NLQ | 2001-11-07 |
| 177649 | 1585198105 | K012571 | REPROCESSED HARMONIC | NLQ | 2001-11-07 |
| 17102 | 1970372285 | K012537 | REPROCESSED IMAGING CATHETERS | OWQ | 2002-10-11 |
| 177649 | 1970372285 | K012537 | REPROCESSED IMAGING CATHETERS | OWQ | 2002-10-11 |
| 177649 | 1852744209 | K012536 | REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES | HRX | 2001-11-02 |
| 17102 | 1852744209 | K012536 | REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES | HRX | 2001-11-02 |
| 177649 | 1632634625 | K012523 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2002-08-14 |
| 17102 | 1632634625 | K012523 | REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS | NLH | 2002-08-14 |
| 177649 | 1063440661 | ||||
| 17102 | 1063440661 | ||||
| 177649 | 1084204416 | ||||
| 17102 | 1084204416 | ||||
| 177649 | 1209232766 | ||||
| 17102 | 1209232766 | ||||
| 17102 | 1372967420 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NLH | 19 | 2024-10-11 |
| NLQ | 14 | 2019-08-15 |
| KTT | 14 | 2016-11-10 |
| NUJ | 14 | 2016-09-20 |
| NLM | 12 | 2014-01-22 |
| OWQ | 11 | 2026-06-29 |
| NLF | 8 | 2011-02-18 |
| QNW | 2 | 2023-11-28 |
| PNE | 2 | 2016-03-23 |
| NDM | 2 | 2010-06-25 |
| ERL | 2 | 2008-12-17 |
| NLU | 2 | 2005-07-20 |
| NON | 2 | 2005-07-20 |
| NMJ | 2 | 2005-07-11 |
| JOW | 2 | 2002-02-11 |
| GEI | 2 | 2001-11-08 |
| HRX | 2 | 2001-11-02 |
| MTD | 1 | 2021-06-23 |
Sterilmed, Inc.
Sterilmed, Inc.
Sterilmed, Inc.
Sterilmed, Inc.
STERILMED, INC.
Sterilmed, Inc.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
STERILMED, INC.
2026-07-06
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2016-09-22
2018-06-18
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