AccessGUDID - DEVICE: Lavior (00860010195703)

GUDID

Device Identifier (DI) Information

Brand Name: Lavior
Version or Model: DWC10US1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lavior Pharma Inc.

Primary DI Number: 00860010195703
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080685327 *Terms of Use

Device Description: Diabetic hydrogel for wounds. LAVIOR Diabetic Hydrogel Wound Dressing is a groundbreaking, clinically proven wound care product. By creating a moist wound environment, LAVIOR Diabetic Hydrogel assists in autolytic debridement of wounds covered with necrotic tissues. Through its healing properties, LAVIOR Diabetic Hydrogel works to promote healing and healthier skin. It is indicated for cuts, scrapes, abrasions, and diabetic skin ulcers.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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
Storage Environment Humidity: less than 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 539c7548-fe92-420f-837b-f0adcb323df7
Public Version Date: October 24, 2023
Public Version Number: 1
DI Record Publish Date: October 16, 2023