AccessGUDID - DEVICE: URGOCELL AG/SILVER (03546890035250)

GUDID

Device Identifier (DI) Information

Brand Name: URGOCELL AG/SILVER
Version or Model: 509345
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABORATOIRES URGO

Primary DI Number: 03546890035250
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397310355 *Terms of Use

Device Description: A non-occlusive semi-permeable absorbent dressing impregnated with Silver Salts derived from Technology Lipido-Colloid (TLC). Composed of 3 layers : - Silver Healing Matrix TLC-Ag made of polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), vaseline, cohesion polymers and Silver salts - an absorbent polyurethane foam pad - a protective polyurethane backing

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?
47042	Wound-nonadherent dressing, absorbent, antimicrobial	A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. 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 77 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4 X 4 inches

Device Record Status

Public Device Record Key: 3f754d17-777c-4020-bacb-c92d7275384d
Public Version Date: October 06, 2021
Public Version Number: 2
DI Record Publish Date: April 26, 2021