AccessGUDID - DEVICE: URGOTUL AG/SILVER (03546890035069)

GUDID

Device Identifier (DI) Information

Brand Name: URGOTUL AG/SILVER
Version or Model: 553228
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABORATOIRES URGO

Primary DI Number: 03546890035069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397310355 *Terms of Use

Device Description: A non-adhesive and non-occlusive dressing consisting of a Silver Healing Matrix made of polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), vaseline, cohesion polymers and Silver salts.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
47203	Wound-nonadherent dressing, permeable, antimicrobial	A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 Temperature: less than 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8 X 16 inches

Device Record Status

Public Device Record Key: c0dff5d1-e629-4364-bde0-f7cba0a04e4b
Public Version Date: October 06, 2021
Public Version Number: 2
DI Record Publish Date: April 26, 2021