AccessGUDID - DEVICE: URGOK2 (00190769532437)

GUDID

Device Identifier (DI) Information

Brand Name: URGOK2
Version or Model: 553243
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 553243
Company Name: URGO MEDICAL NORTH AMERICA, LLC

Primary DI Number: 00190769532437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052758618 *Terms of Use

Device Description: UrgoK2 is a two Layer Compression System -KTECH; a short - stretch bandage, providing compression, protection and absorbency and KPRESS; a cohesive long-stretch bandage providing the compression necessary to achieve therapeutic pressure and secures the bandages in place. UrgoK2 is for the treatment of venous leg ulcers, venous edema and lymphedema requiring full compression. Not made with natural rubber latex.

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:	Yes
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?
58983	Compression bandaging kit	A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	Bandage, Elastic

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store away from light and heat.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Width of bandages: 4 inches (10 cm)
Device Size Text, specify: For Ankle circumference: 7 1/8 - 9 3/4 inches (18 - 25 cm)
Device Size Text, specify: KPRESS = 7.8 yards stretched
Device Size Text, specify: KTECH = 6.6 yards

Device Record Status

Public Device Record Key: f626ef75-8624-47a4-ad6d-74a2a873c36b
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: December 26, 2019