AccessGUDID - DEVICE: URGOK2 LITE (03546890028450)

GUDID

Device Identifier (DI) Information

Brand Name: URGOK2 LITE
Version or Model: 553246
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABORATOIRES URGO

Primary DI Number: 03546890028450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397310355 *Terms of Use

Device Description: A 2-layer reduced multicomponent compression bandage system, composed of a short stretch bandage and a long stretch bandage. Layer 1, KTECH Lite/KTECH Reduced composition: wadding: viscose, polyester; knitted layer: polyamide, elastane. Layer 2, KPRESS composition: cotton, polyester, polyamide, elastane; synthetic latex free cohesive material.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Width of bandages: 4 inches (10 cm)
Device Size Text, specify: For Ankle circumference: 9 3/4 - 12 1/2 inches (25 - 32 cm)
Device Size Text, specify: KTECH (Lite) length = 8 yards
Device Size Text, specify: KPRESS length = 11.5 yards stretched

Device Record Status

Public Device Record Key: 327ee719-3413-4c55-abc6-fb959e86998b
Public Version Date: November 20, 2024
Public Version Number: 4
DI Record Publish Date: April 26, 2021