AccessGUDID - DEVICE: Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3 (00851383003016)

GUDID

Device Identifier (DI) Information

Brand Name: Drawtex Hydroconductive Wound Dressing with LevaFiber 3X3
Version or Model: 00301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00301
Company Name: URGO MEDICAL NORTH AMERICA, LLC

Primary DI Number: 00851383003016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052758618 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 40 Percent (%) Relative Humidity
Storage Environment Temperature: between 46 and 59 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 3 Square inch

Device Record Status

Public Device Record Key: 4acb64cc-3ac6-4b54-be56-e02ce68275c3
Public Version Date: January 26, 2022
Public Version Number: 3
DI Record Publish Date: November 01, 2019