AccessGUDID - DEVICE: UrgoTul Absorb Border (00190769507657)

GUDID

Device Identifier (DI) Information

Brand Name: UrgoTul Absorb Border
Version or Model: 550765
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 550765
Company Name: URGO MEDICAL NORTH AMERICA, LLC

Primary DI Number: 00190769507657
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052758618 *Terms of Use

Device Description: A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix with a vapor permeable waterproof outer film with silicone adhesive on the edges.

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):	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?
43186	Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAD	Dressing, Wound, Occlusive

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 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: Sacrum 8 X 8 inch

Device Record Status

Public Device Record Key: f6f23d20-1cff-431e-95d0-4b6360872fc8
Public Version Date: July 22, 2021
Public Version Number: 5
DI Record Publish Date: March 01, 2019