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

Initial Importer

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