Urgo Medical North America L L C

FDA Filings

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

Urgo Medical North America L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Allan Couch
• Norma Schafer

FDA Registration(s)

• Registration Number: 3010060216
• FEI Number: 3010060216
• Name: URGO Medical North America, LLC
• Owner & Operator: URGO Medical North America LLC
• Contact Address: 3801 Hulen Street Suite 251; Fort Worth TX 76107 US
• Official Correspondent:
  • Norma Schafer
  • x-817-5290956-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3801 Hulen St Ste 251 ; Fort Worth, TX 76107 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10190769085961 URGO MEDICAL NORTH AMERICA, LLC	Resta Silver Gel Bellows Bottle 08596	2021-12-15
GUDID 10190769004054 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution OTC 00405	2021-12-15
GUDID 00190769085971 URGO MEDICAL NORTH AMERICA, LLC	Resta Silver Gel Tube 08597	2021-12-15
GUDID 10851383003235 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container 00323	2020-04-09
GUDID 10851383003228 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 1 L (34 fl oz) Flip Top Container 00322	2020-04-09
GUDID 10851383003174 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 475 ml (16 fl oz) Instillation Container 00317	2020-04-09
GUDID 10190769532465 URGO MEDICAL NORTH AMERICA, LLC	URGOK2 Lite (Long) Kit 553246	2020-02-20
GUDID 00190769532451 URGO MEDICAL NORTH AMERICA, LLC	URGOK2 Lite (Short) Kit 553245	2020-02-20
GUDID 10851383003167 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container 00316	2020-02-17
GUDID 10851383003143 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container 00314	2020-02-11
GUDID 00851383003528 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap 00352	2020-02-11
GUDID 00851383003139 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap 00313	2020-02-11
GUDID 00190769532284 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Ag/Silver 8X16 553228	2020-02-11
GUDID 10190769532434 URGO MEDICAL NORTH AMERICA, LLC	URGOK2 (Short) Kit 553243	2020-01-03
GUDID 00190769532444 URGO MEDICAL NORTH AMERICA, LLC	URGOK2 (Long) Kit 553244	2019-12-30
GUDID 10851383003129 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wound Solution 118 ml container - Flip Cap	2019-12-10
GUDID 00851383003214 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 00321	2019-12-10
GUDID 10190769093461 URGO MEDICAL NORTH AMERICA, LLC	UrgoCell Ag/ Silver Foam 6 X 8 509346	2019-11-25
GUDID 10190769093454 URGO MEDICAL NORTH AMERICA, LLC	UrgoCell Ag/Silver Foam 4 X 4 509345	2019-11-25
GUDID 10190769093423 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Ag/Silver Contact Layer 6 X 8 509342	2019-11-25
GUDID 10190769093416 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Ag/Silver Contact Layer 4 X 5 509341	2019-11-25
GUDID 00851383003108 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber TRACH 4X4 00310	2019-11-11
GUDID 00851383003078 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 39X8 00307	2019-11-11
GUDID 00851383003061 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 4 X 39 00306	2019-11-11
GUDID 00851383003054 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 3X39 00305	2019-11-11
GUDID 00851383003047 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 8X8 00304	2019-11-11
GUDID 00851383003030 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 6X8 00303	2019-11-11
GUDID 00851383003023 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 4X4 00302	2019-11-11
GUDID 00851383003016 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 00301	2019-11-11
GUDID 00851383003009 URGO MEDICAL NORTH AMERICA, LLC	Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 00300	2019-11-11
GUDID 10190769507654 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Border Sacrum 8 X 8 550765	2019-10-15
GUDID 10190769507647 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Border 6 X 8 550764	2019-10-15
GUDID 10190769507630 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Border 6 X 6 550763	2019-10-15
GUDID 10190769507623 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Border 4 X 4 550762	2019-10-15
GUDID 10190769093843 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Non-Border Heel 5 X 7.5 509384	2019-10-15
GUDID 10190769093829 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Non-Border 6 X 6 509382	2019-10-15
GUDID 10190769093812 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Non-Border 4 X 4 509381	2019-10-15
GUDID 10190769093805 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Absorb Foam Non-Border 2.5 X 2.5 509380	2019-10-15
GUDID 10190769064898 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Contact Layer 6X8 506489	2019-10-15
GUDID 10190769064881 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Contact Layer 4 X 5 506488	2019-10-15
GUDID 10190769064874 URGO MEDICAL NORTH AMERICA, LLC	UrgoTul Contact Layer 2 X 2 inch 506487	2019-10-15
GUDID 10190769003552 URGO MEDICAL NORTH AMERICA, LLC	Vashe Sterile Sleeve 00355	2019-10-15
GUDID 10190769003545 URGO MEDICAL NORTH AMERICA, LLC	Vashe Wipes Skin Cleansing Solution Kit 00354	2019-10-15
PMN K131848 | FRO URGO Medical North America, LLC [URGO Medical North America LLC]	Vashe Wound Solution	2016-05-31