Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3

Basic Information

• Brand Name: Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3
• Primary DI: 00851383003016
• Version / Model: 00301
• Catalog Number: 00301
• Company Name: URGO MEDICAL NORTH AMERICA, LLC
• Labeler DUNS: 052758618
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-01
• Public Version: 3
• Public Version Date: 2022-01-26
• Public Version Status: Update
• Public Device Record Key: 4acb64cc-3ac6-4b54-be56-e02ce68275c3

Device Description

Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 (1 bx of 10 dressings) 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).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851383003016	GS1
Package	10851383003013	GS1	Carton	10	In Commercial Distribution
Package	20851383003010	GS1	Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	3	Square inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 40 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 46 – 59 Degrees Fahrenheit