AccessGUDID - DEVICE: UrgoTul Ag/Silver (00190769532284)

GUDID

Device Identifier (DI) Information

Brand Name: UrgoTul Ag/Silver
Version or Model: 553228
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 553228
Company Name: URGO MEDICAL NORTH AMERICA, LLC

Primary DI Number: 00190769532284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052758618 *Terms of Use

Device Description: Contact Layer Silver is a non-adhesive, non-occlusive, antimicrobial wound contact dressing, composed of a polyester mesh impregnated with a matrix of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petrolatum and silver. Not made with natural rubber.

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: between 0 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store away from light.

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 458c059a-a23e-4d15-98c3-926cec4092fc
Public Version Date: September 11, 2020
Public Version Number: 3
DI Record Publish Date: February 03, 2020