Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 00321

GUDID 00851383003214

Drawtex Hydroconductive Wound Dressing with LevaFiber 18X0.39 (1 bx of 10 strips) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV).

URGO MEDICAL NORTH AMERICA, LLC

Wound-nonadherent dressing, absorbent, sterile Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial

Primary Device ID	00851383003214
NIH Device Record Key	e60032c5-17e2-462c-b777-ddf346035d4c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39
Version Model Number	00321
Catalog Number	00321
Company DUNS	052758618
Company Name	URGO MEDICAL NORTH AMERICA, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com
Phone	1-855-888-8273
Email	info@us.urgo.com

Device Dimensions

Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch
Width	0.39 Inch
Height	18 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Storage Environment Temperature	Between 46 Degrees Fahrenheit and 59 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851383003214 [Primary]
GS1	10851383003211 [Package] Package: Carton [10 Units] In Commercial Distribution
GS1	20851383003218 [Package] Contains: 10851383003211 Package: Case [10 Units] In Commercial Distribution

FDA Product Code

NAC	Dressing, Wound, Hydrophilic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-10
Device Publish Date	2019-12-02

Devices Manufactured by URGO MEDICAL NORTH AMERICA, LLC

10190769004054 - Vashe Wound Solution OTC	2021-12-15 Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in
10190769085961 - Resta Silver Gel Bellows Bottle	2021-12-15 Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacera
00190769085971 - Resta Silver Gel Tube	2021-12-15 Resta SilverGel is a crystal-clear antimicrobial silver gel indicated for the management of minor bums, superficial cuts, lacera
10851383003174 - Vashe Wound Solution 475 ml (16 fl oz) Instillation Container	2020-04-09 Vashe Wound solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption
10851383003228 - Vashe Wound Solution 1 L (34 fl oz) Flip Top Container	2020-04-09 Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption
10851383003235 - Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container	2020-04-09 Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption
00190769532451 - URGOK2 Lite (Short) Kit	2020-02-20 URGOK2 Lite is a two layer Compression System which includes KTECH Lite: a white, short-stretch bandage; providing compression,
10190769532465 - URGOK2 Lite (Long) Kit	2020-02-20 URGOK2 Lite is a two layer system including KTECH Lite: a white, short-stretch bandage; providing compression, protection and a