Summit Medical Products Inc

FDA Filings

This page includes the latest FDA filings for Summit Medical Products Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Summit Medical Products Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Sigi Caron

FDA Registration(s)

• Registration Number: 1722214
• FEI Number: 1000117099
• Name: Summit Medical Products, inc
• Owner & Operator: Summit Medical Products, Inc.
• Contact Address: 504 West 8360 South ; Sandy UT 84070 US
• Official Correspondent:
  • LeVoy Haight
  • x-801-3521888-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 504 West 8360 South ; Sandy, UT 84070 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10850000509235 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220582	2021-06-18
GUDID 00850000509078 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220571	2020-08-25
GUDID 20850000509065 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220575	2020-05-14
GUDID 00857595005923 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220540	2020-05-14
GUDID 20850000509041 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220573	2020-05-01
GUDID 00850000509054 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220574	2020-05-01
GUDID 00850000509030 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220572	2020-05-01
GUDID 00850000509023 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220546	2020-05-01
GUDID 20850000509010 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220569	2020-03-26
GUDID 20850000509003 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220568	2020-03-26
GUDID 20857595005910 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220539	2020-03-05
GUDID 20857595005903 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220542	2020-03-05
GUDID 20857595005897 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220541	2020-03-05
GUDID 20857595005880 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220537	2020-03-05
GUDID 20857595005804 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220532	2020-03-05
GUDID 20857595005798 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220528	2020-03-05
GUDID 20857595005996 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220563	2020-01-27
GUDID 20857595005989 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220562	2020-01-27
GUDID 20857595005972 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220561	2020-01-27
GUDID 20857595005965 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220560	2020-01-27
GUDID 20857595005101 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220514Y	2019-12-23
GUDID 20857595005255 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220343	2019-12-20
GUDID 20857595005248 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220342	2019-12-20
GUDID 20857595005736 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220524	2019-10-07
GUDID 20857595005125 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220278	2019-10-07
GUDID 20857595005118 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220121	2019-10-07
GUDID 20857595005866 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220533	2019-09-13
GUDID 20857595005842 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220530	2019-09-13
GUDID 20857595005835 SUMMIT MEDICAL PRODUCTS, INC.	MediBag 220529	2019-09-13
GUDID 20857595005439 SUMMIT MEDICAL PRODUCTS, INC.	Uni-Flo 220491	2019-02-07
GUDID 20857595005422 SUMMIT MEDICAL PRODUCTS, INC.	Uni-Flo 220490	2019-02-07
GUDID 20857595005415 SUMMIT MEDICAL PRODUCTS, INC.	Uni-Flo 220489	2019-02-07
GUDID 20857595005873 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220514	2019-01-07
GUDID 00857595005787 SUMMIT MEDICAL PRODUCTS, INC.	Brio Device, LLC 220498	2019-01-07
GUDID 20857595005552 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220517Y	2018-10-15
GUDID 20857595005545 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220517	2018-10-15
GUDID 20857595005095 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220267	2018-10-15
GUDID 20857595005088 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220266Y	2018-10-15
GUDID 20857595005071 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220266	2018-10-15
GUDID 20857595005064 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220140Y	2018-10-15
GUDID 20857595005057 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220140B	2018-10-15
GUDID 20857595005040 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220140	2018-10-15
GUDID 20857595005033 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220139	2018-10-15
GUDID 20857595005026 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220418	2018-10-15
GUDID 00857595005695 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220501Y	2018-10-15
GUDID 00857595005688 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220501	2018-10-15
GUDID 00857595005671 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220437	2018-10-15
GUDID 00857595005664 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220476	2018-10-15
GUDID 00857595005640 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220468	2018-10-15
GUDID 00857595005626 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220461	2018-10-15
GUDID 00857595005619 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220452	2018-10-15
GUDID 00857595005602 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220426	2018-10-15
GUDID 00857595005596 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220326	2018-10-15
GUDID 20857595005132 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220332	2018-10-04
GUDID 00857595005213 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220493	2018-09-13
GUDID 00857595005817 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220534	2018-08-16
GUDID 00857595005824 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220527	2018-07-23
GUDID 20857595005347 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220473	2018-05-22
GUDID 20857595005149 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220266mil	2018-05-22
GUDID 20857595005729 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220523	2018-03-29
GUDID 20857595005453 SUMMIT MEDICAL PRODUCTS, INC.	Micro iBlade 220497B	2018-03-29
GUDID 20857595005446 SUMMIT MEDICAL PRODUCTS, INC.	Micro iBlade 220497A	2018-03-29
GUDID 20857595005354 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220477	2018-03-29
GUDID 20857595005330 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220472	2018-03-29
GUDID 20857595005323 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220471	2018-03-29
GUDID 20857595005316 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220470	2018-03-29
GUDID 20857595005309 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220469	2018-03-29
GUDID 20857595005286 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220462	2018-03-29
GUDID 20857595005279 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220449	2018-03-29
GUDID 20857595005262 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220344	2018-03-29
GUDID 20857595005200 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220466	2018-03-29
GUDID 20857595005194 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220463	2018-03-29
GUDID 20857595005187 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220451	2018-03-29
GUDID 20857595005170 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220405	2018-03-29
GUDID 20857595005163 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220404	2018-03-29
GUDID 20857595005156 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220316	2018-03-29
GUDID 00857595005589 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220262	2018-03-29
GUDID 00857595005572 SUMMIT MEDICAL PRODUCTS, INC.	ambIT 220244	2018-03-29
BSR Summit Medical Products, inc [Summit Medical Products, Inc.]	INT NAVIGATOR	2018-03-21
BSR Summit Medical Products, inc [Summit Medical Products, Inc.]	Brio INT Navigator Intubating Stylet	2018-03-21
MEA Summit Medical Products, inc [Summit Medical Products, Inc.]	ambIT Programmable PreSet Pump	2017-11-09
FRN Summit Medical Products, inc [Summit Medical Products, Inc.]	ambIT Programmable PreSet Pump	2017-11-09
PMN K162165 | MEA Summit Medical Products, inc [Summit Medical Products, Inc.]	ambIT PIB/PCA v 1.5	2017-10-26
PMN K162165 | MEA Summit Medical Products, inc [Summit Medical Products, Inc.]	PIB IL	2017-10-26
PMN K162165 | MEA Summit Medical Products, inc [Summit Medical Products, Inc.]	KIDS PIB	2017-10-26
PMN K162165 | FRN Summit Medical Products, inc [Summit Medical Products, Inc.]	ambIT PIB/PCA v 1.5	2017-10-26
PMN K162165 | FRN Summit Medical Products, inc [Summit Medical Products, Inc.]	PIB IL	2017-10-26
PMN K162165 | FRN Summit Medical Products, inc [Summit Medical Products, Inc.]	KIDS PIB	2017-10-26
PMN K162165 SUMMIT MEDICAL PRODUCTS, INC	AmbIT PCA*PIB, AmbIT PIB, AmbIT PIB*PCA, AmbIT PIEB, And AmbIT Programmable Intermittent Pump	2017-08-29
GES Summit Medical Products, inc [Summit Medical Products, Inc.]	iBlade	2016-10-27
GES Summit Medical Products, inc [Summit Medical Products, Inc.]	Micro iBlade	2016-10-27
GES Summit Medical Products, inc [Summit Medical Products, Inc.]	MICROi	2016-10-27
GES Summit Medical Products, inc [Summit Medical Products, Inc.]	MICROi Blade	2016-10-27
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220575	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220574	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220573	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220568	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220509	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220508	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220507	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220493	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220481 NZ	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220481 AUS	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220477	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220473	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220472	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220471	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220470	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220469	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220466	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220463	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220462	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220451	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220449	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220405	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220404	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220344	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220343	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220342	2016-08-08
OFQ Summit Medical Products, inc [Summit Medical Products, Inc.]	220316	2016-08-08
PMN K113043 SUMMIT MEDICAL PRODUCTS, INC	DIRECT ANTIBIOTIC INFUSION KIT	2011-12-20
PMN K110814 SUMMIT MEDICAL PRODUCTS, INC	AMBIT TUNNELER	2011-04-08
PMN K102460 SUMMIT MEDICAL PRODUCTS, INC	AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH	2011-01-13
PMN K052221 | FRN Summit Medical Products, inc [Summit Medical Products, Inc.]	St. Luke's Preset	2009-08-04
PMN K001287 | KPE Summit Medical Products, inc [Summit Medical Products, Inc.]	Medibag 500	2009-08-04
PMN K001287 | KPE Summit Medical Products, inc [Summit Medical Products, Inc.]	Medibag 250	2009-08-04
PMN K001287 | KPE Summit Medical Products, inc [Summit Medical Products, Inc.]	MediBag 420	2009-08-04
PMN K001287 | KPE Summit Medical Products, inc [Summit Medical Products, Inc.]	MediBag 100	2009-08-04

Related Finance Registrations

NCAGE Code	25532	SUMMIT MEDICAL PRODUCTS INC
NCAGE Code	5SXW0	SUMMIT MEDICAL PRODUCTS, INC.
CAGE Code	25532	SUMMIT MEDICAL PRODUCTS INC
CAGE Code	5SXW0	SUMMIT MEDICAL PRODUCTS, INC.
S.A.M. Registration	5SXW0 [831704841]	SUMMIT MEDICAL PRODUCTS, INC.
S.A.M. Registration	5SXW0 [831704841]	SUMMIT MEDICAL PRODUCTS, INC.
DUNS	831704841	SUMMIT MEDICAL PRODUCTS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201809088869	Hong Kong,Hong Kong -> Los Angeles, California	30910 A AMBLT BUTTON GUARD WITH BUTTON ACCESS	50 CTN
2018081549232	Hong Kong,Hong Kong -> Los Angeles, California	INSERTION TOOL	50 CTN