Lavior

GUDID 00860010195703

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.

Lavior Pharma Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00860010195703
NIH Device Record Key539c7548-fe92-420f-837b-f0adcb323df7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLavior
Version Model NumberDWC10US1
Company DUNS080685327
Company NameLavior Pharma Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com
Phone(305) 627-3680
Emailinfo@lavior.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010195703 [Primary]

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-24
Device Publish Date2023-10-16

On-Brand Devices [Lavior]

00860010195703Diabetic hydrogel for wounds. LAVIOR Diabetic Hydrogel Wound Dressing is a groundbreaking, clin
00860010195734LAVIOR Hydrogel Wound Dressing helps to enhance wound recovery by providing a moist, wound-heali

Trademark Results [Lavior]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LAVIOR
LAVIOR
87134822 not registered Live/Pending
LAVIOR INC
2016-08-11

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