Heraeus Medical Components L L C

FDA Filings

This page includes the latest FDA filings for Heraeus Medical Components L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008988055
• FEI Number: 3008988055
• Name: HERAEUS MEDICAL COMPONENTS, LLC
• Owner & Operator: Heraeus Medical Components, LLC
• Contact Address: 5030 Centerville Road ; Saint Paul MN 55127 US
• Official Correspondent:
  • Jose E Cabrera
  • 01-612-3839199-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5030 Centerville Road ; Saint Paul, MN 55127 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3005029049
• FEI Number: 3005029049
• Name: Heraeus Medical Components Caribe, Inc.
• Owner & Operator: Heraeus Medical Components, LLC
• Contact Address: 5030 Centerville Road ; Saint Paul MN 55127 US
• Official Correspondent:
  • Jose Cabrera
  • 1-651-7928561-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 415 ROAD 693 ; DORADO, PR 00646 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3013666336
• FEI Number: 3013666336
• Name: Heraeus Medical Components, SRL
• Owner & Operator: Heraeus Medical Components, LLC
• Contact Address: 5030 Centerville Road ; Saint Paul MN 55127 US
• Official Correspondent:
  • Jose E Cabrera
  • 01-612-3839199-x
• US Agent:
  • Jose E. Cabrera
  • 612 3839199
  • jose.cabrera@heraeus.com
• Importing Logistics Registration:
  • Importer: Bard Operations Center
  • Address: 201 W Anaya Road ; Pharr, TX 78577 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Parque Industrial Zona Franca La Lima Guadalupe, Building 29; Cartago Cartago, 30106 CR
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006722742
• FEI Number: 3006722742
• Name: HERAEUS MEDICAL COMPONENTS, LLC
• Owner & Operator: Heraeus Medical Components, LLC
• Contact Address: 5030 Centerville Road ; Saint Paul MN 55127 US
• Official Correspondent:
  • Jose E Cabrera
  • 01-612-3839199-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1350 Energy Lane Suite 100; Saint Paul, MN 55108 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00827002448551 HERAEUS MEDICAL COMPONENTS LLC	Motion Hybrid Wire Guide	2021-09-17
GUDID 00827002448490 HERAEUS MEDICAL COMPONENTS LLC	Motion Hybrid Wire Guide	2021-09-17
GUDID 00827002448483 HERAEUS MEDICAL COMPONENTS LLC	Motion Hybrid Wire Guide	2021-09-17
GUDID 00827002448469 HERAEUS MEDICAL COMPONENTS LLC	Motion Hybrid Wire Guide	2021-09-17
GUDID 08714729892045 HERAEUS MEDICAL COMPONENTS LLC	NovaGold	2021-08-24
GUDID 08714729892038 HERAEUS MEDICAL COMPONENTS LLC	NovaGold	2021-08-24
GUDID 00816840020777 HERAEUS MEDICAL COMPONENTS LLC	Approach Authority Workhorse Microwire Guide	2020-06-29
GUDID 00816840020760 HERAEUS MEDICAL COMPONENTS LLC	Approach Authority Workhorse Microwire Guide	2020-06-29
PMN K191305 Heraeus Medical Components, LLC	Hereaeus Poseidon Microcatheter	2019-12-19
PMN K191502 Heraeus Medical Components, LLC	Heraeus Peripheral Guidewire	2019-11-26
GUDID 00857834006933 HERAEUS MEDICAL COMPONENTS, LLC	Odyssey Micro Catheter	2019-04-09
GUDID 00857834006605 HERAEUS MEDICAL COMPONENTS, LLC	Odyssey Micro Catheter	2019-04-09
GUDID 00857834006384 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006377 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006360 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006353 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006346 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006339 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006322 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006315 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006308 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006292 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006285 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006278 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006261 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006254 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006247 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006230 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006223 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006216 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006209 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006193 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006186 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006179 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006162 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006155 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006148 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006131 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006124 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006117 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006100 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006094 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006087 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00857834006070 HERAEUS MEDICAL COMPONENTS, LLC	ERCP	2018-10-05
GUDID 00816840020487 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020470 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020463 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020456 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020449 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020432 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020425 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020418 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020401 HERAEUS MEDICAL COMPONENTS, LLC	TMW	2018-09-03
GUDID 00816840020395 HERAEUS MEDICAL COMPONENTS, LLC	TMW	2018-09-03
GUDID 00816840020388 HERAEUS MEDICAL COMPONENTS, LLC	TMW	2018-09-03
GUDID 00816840020371 HERAEUS MEDICAL COMPONENTS, LLC	TMW	2018-09-03
GUDID 00816840020364 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020357 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020340 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020333 HERAEUS MEDICAL COMPONENTS, LLC	SOLO FLEX Hybrid Guidewires	2018-09-03
GUDID 00816840020326 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020319 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020302 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020296 HERAEUS MEDICAL COMPONENTS, LLC	SOLO PLUS Stiff Hybrid Guidewires	2018-09-03
GUDID 00816840020227 HERAEUS MEDICAL COMPONENTS, LLC	Bard Solo Hydro Urology Wire	2018-09-03
GUDID 00816840020210 HERAEUS MEDICAL COMPONENTS, LLC	Bard Solo Hydro Urology Wire	2018-09-03
GUDID 00816840020203 HERAEUS MEDICAL COMPONENTS, LLC	Bard Solo Hydro Urology Wire	2018-09-03
GUDID 00816840020197 HERAEUS MEDICAL COMPONENTS, LLC	Bard Solo Hydro Urology Wire	2018-09-03
GUDID 00857834006902 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006896 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006889 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006872 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006865 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006858 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006841 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006834 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006827 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006810 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006803 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006797 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006780 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006773 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006766 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006759 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006728 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006711 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006704 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006698 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006681 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006674 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006667 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006650 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006643 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006636 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006629 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006612 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006599 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006582 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006575 HERAEUS MEDICAL COMPONENTS, LLC	Selectiva	2018-07-06
GUDID 00857834006551 HERAEUS MEDICAL COMPONENTS, LLC	Bard Snare OUS	2018-07-06
GUDID 00857834006544 HERAEUS MEDICAL COMPONENTS, LLC	Bard Snare US	2018-07-06
GUDID 00857834006391 HERAEUS MEDICAL COMPONENTS, LLC	Spring Coil Guidewire	2018-07-06
PMN K170664 | DQY HERAEUS MEDICAL COMPONENTS, LLC	Odyssey Micro Catheter	2017-11-10
PMN K170664 Heraeus Medical Components, LLC	Odyssey Micro Catheter	2017-11-09
PMN K173052 | DQX HERAEUS MEDICAL COMPONENTS, LLC	TMW Guidewire	2017-10-23
PMN K173052 Heraeus Medical Components, LLC	Heraeus TMW Guidewire	2017-10-20
PMN K152560 | MMX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Bard Snare Retrieval Kit	2016-03-31
PMN K152560 | MMX HERAEUS MEDICAL COMPONENTS, LLC	Bard Snare Retrieval Kit	2016-03-31
PMN K143135 | DQX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Spring Coil Guidewire	2015-02-24
PMN K143135 | DQX HERAEUS MEDICAL COMPONENTS, LLC	Spring Coil Guidewire	2015-02-24
PMN K070150 | DQX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Vascupuncture Guidewires	2007-10-16
PMN K070150 | DQX HERAEUS MEDICAL COMPONENTS, LLC	Vascupuncture Guidewires	2007-10-16
PMN K043398 | DQX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Vascupuncture Guidewires	2007-10-16
PMN K043398 | DQX HERAEUS MEDICAL COMPONENTS, LLC	Vascupuncture Guidewires	2007-10-16
PMN K040786 | DQX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Vascupuncture Guidewires	2007-10-16
PMN K040786 | DQX HERAEUS MEDICAL COMPONENTS, LLC	Vascupuncture Guidewires	2007-10-16
PMN K031652 | DQX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Vascupuncture Guidewires	2007-10-16
PMN K031652 | DQX HERAEUS MEDICAL COMPONENTS, LLC	Vascupuncture Guidewires	2007-10-16
PMN K012861 | DQX Heraeus Medical Components, SRL [Heraeus Medical Components, LLC]	Vascupuncture Guidewires	2007-10-16
PMN K012861 | DQX HERAEUS MEDICAL COMPONENTS, LLC	Vascupuncture Guidewires	2007-10-16

Related Finance Registrations

NCAGE Code	89KQ2	HERAEUS MEDICAL COMPONENTS LLC
CAGE Code	89KQ2	HERAEUS MEDICAL COMPONENTS LLC
S.A.M. Registration	89KQ2 [868303074]	HERAEUS MEDICAL COMPONENTS LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019080162644	Puerto Limon,Costa Rica -> New York, New York	MASTER GRINDER	3 PKG
20180219997	Singapore,Singapore -> Los Angeles, California	GRIND WHEEL RACK	1 PKG
20180202508	Singapore,Singapore -> Los Angeles, California	GRIND WHEEL RACK	1 PKG
20180201611	Singapore,Singapore -> Los Angeles, California	GRIND WHEEL RACK	1 PKG
201801052572	Singapore,Singapore -> Los Angeles, California	GRIND WHEEL RACK	1 PKG