VitroPRO
CIVCO Medical Instruments Co., Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3034286426 | 1937223 | CIVCO Medical Instruments Co., Inc. | 1 | N | 2026-01-01 | 750 Lois Lane Coralville IA US 52241 |
| 1937223 | 1937223 | CIVCO Medical Instruments Co., Inc. | 1 | N | 2020-04-25 | 102 FIRST ST. SOUTH Kalona IA US 52247 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00841436125413 | Tracking Bracket Starter Kit - Reusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5) for use with Samsung Medison BCL2-14 transducers | +1(319)248-6502 | regulatory@civco.com |
| 00841436125420 | Tracking Bracket - Reusable non-sterile tracking bracket for use with Samsung Medison BCL2-14 transducers | +1(319)248-6502 | regulatory@civco.com |
| 00841436126212 | Tracking Bracket Starter Kit - Reusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5) for use with Samsung Medison EA2-12SR/EA2-12SV transducers | +1(319)248-6502 | regulatory@civco.com |
| 00841436126229 | Tracking Bracket - Reusable non-sterile tracking bracket for use with Samsung Medison EA2-12SR/EA2-12SV transducers | +1(319)248-6502 | regulatory@civco.com |
| 00841436126328 | Tracking Bracket - Reusable non-sterile tracking bracket for use with Samsung Medison CM1-8 and CM2-11 transducers | +1(319)248-6502 | regulatory@civco.com |
| 00841436126588 | Tracking Bracket Starter Kit - Reusable non-sterile tracking bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex™ covers (5) for use with GE Healthcare IC5-9 transducers | +1(319)248-6502 | regulatory@civco.com |
| 00841436126595 | Tracking Bracket - Reusable non-sterile tracking bracket for use with GE Healthcare IC5-9 transducers | +1(319)248-6502 | regulatory@civco.com |
| 10841436101865 | eTRAX™ Needle - Sterile needle, 16GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVCO 16GA needle sensor | +1(319)248-6502 | regulatory@civco.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 335073 | 1261918852 | K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF | ITX | 1999-08-17 |
| 33808 | 1261918852 | K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF | ITX | 1999-08-17 |
| 335073 | 1870868781 | K972672 | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY | ITX | 1997-07-29 |
| 33808 | 1870868781 | K972672 | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY | ITX | 1997-07-29 |
| 33808 | 1096800380 | K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | ITX | 1997-06-20 |
| 335073 | 1096800380 | K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | ITX | 1997-06-20 |
| 33808 | 1538451169 | K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | ITX | 1997-06-20 |
| 335073 | 1538451169 | K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | ITX | 1997-06-20 |
| 33808 | 1079681856 | K970513 | GENERAL PURPOSE TRANDUCER COVER | ITX | 1997-06-20 |
| 335073 | 1079681856 | K970513 | GENERAL PURPOSE TRANDUCER COVER | ITX | 1997-06-20 |
| 33808 | 1626109211 | K943393 | CIVCO PROBE BOOT/CORD COVER | KKX | 1995-02-02 |
| 33808 | 1099402808 | K895614 | CIVCO LATEX ULTRASOUND SHEATHS | IYO | 1989-12-14 |
| 33808 | 1862926184 | K875240 | TRANS/V NEEDLE GUIDE | IYO | 1988-04-15 |
| 335073 | 1862926184 | K875240 | TRANS/V NEEDLE GUIDE | IYO | 1988-04-15 |
| 33808 | 1711709596 | K875236 | TRANS/P NEEDLE GUIDE | IYO | 1988-04-15 |
| 335073 | 1711709596 | K875236 | TRANS/P NEEDLE GUIDE | IYO | 1988-04-15 |
| 33808 | 1207911665 | K875128 | TRANS/R NEEDLE GUIDE | IYO | 1988-04-15 |
| 335073 | 1207911665 | K875128 | TRANS/R NEEDLE GUIDE | IYO | 1988-04-15 |
| 335073 | 1855693362 | K233109 | TP Pivot Pro™ Needle Guide | ITX | 2023-12-22 |
| 335073 | 1315777367 | K231783 | VitroPRO | ITX | 2023-11-14 |
| 335073 | 1665606171 | K211270 | CIV-Clear cover | ITX | 2021-09-13 |
| 33808 | 1647373521 | K190802 | Envision ultrasound pad and cover | ITX | 2019-05-24 |
| 335073 | 1647373521 | K190802 | Envision ultrasound pad and cover | ITX | 2019-05-24 |
| 33808 | 1519383855 | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | NEU | 2018-08-02 |
| 33808 | 1695130570 | K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | ITX | 2017-06-09 |
| 335073 | 1695130570 | K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | ITX | 2017-06-09 |
| 335073 | 1491224970 | K160806 | Verza Guidance System | ITX | 2016-08-05 |
| 33808 | 1491224970 | K160806 | Verza Guidance System | ITX | 2016-08-05 |
| 33808 | 2020274909 | K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | PSW | 2015-11-16 |
| 335073 | 2020274909 | K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | PSW | 2015-11-16 |
| 33808 | 1168534556 | K143396 | omni TRAX Active Patient Tracker | IYO | 2015-01-23 |
| 335073 | 1168534556 | K143396 | omni TRAX Active Patient Tracker | IYO | 2015-01-23 |
| 335073 | 2034582195 | K143333 | Revital-Ox RESERT Solution Test Strip | JOJ | 2015-04-14 |
| 33808 | 1154831626 | K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | ITX | 2013-09-17 |
| 335073 | 1154831626 | K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | ITX | 2013-09-17 |
| 33808 | 1968831594 | K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | ITX | 2010-01-19 |
| 335073 | 1968831594 | K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | ITX | 2010-01-19 |
| 33808 | 2073595055 | K092619 | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER | IYO | 2009-11-13 |
| 335073 | 2073595055 | K092619 | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER | IYO | 2009-11-13 |
| 335073 | 1507423446 | K091022 | MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT | MED | 2010-04-12 |
| 335073 | 1885808445 | K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | ITX | 2003-01-22 |
| 33808 | 1885808445 | K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | ITX | 2003-01-22 |
| 33808 | 1285971794 | K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | ITX | 2001-12-28 |
| 335073 | 1285971794 | K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | ITX | 2001-12-28 |
| 33808 | 1358417921 | ||||
| 33808 | 1435327554 | ||||
| 33808 | 1808689023 | ||||
| 33808 | 1836139176 | ||||
| 33808 | 1906975656 | ||||
| 335073 | 1352298856 | ||||
| 335073 | 1358417921 | ||||
| 335073 | 1435327554 | ||||
| 335073 | 1544214867 | ||||
| 335073 | 1808689023 | ||||
| 335073 | 1836139176 |
CIVCO Medical Instruments Co., Inc.
CIVCO Medical Instruments Co., Inc.
CIVCO Medical Instruments Co., Inc.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
CIVCO MEDICAL INSTRUMENTS CO., INC.
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