Atopavo

GUDID 00860003521205

Atopavo is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, Atopavo provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.

ONPACE PHARMA LLC

Skin osmotic dressing, non-antimicrobial
Primary Device ID00860003521205
NIH Device Record Key11d8e780-a053-4781-8823-d14646949510
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtopavo
Version Model Number102-001
Company DUNS081039213
Company NameONPACE PHARMA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com
Phone(228)207-8112
Emailsales@onpacepharma.com

Device Dimensions

Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram
Weight45 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature, do not freeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003521205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-03
Device Publish Date2020-06-25

Devices Manufactured by ONPACE PHARMA LLC

00860003521205 - Atopavo2020-07-03Atopavo is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, Atopavo provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
00860003521205 - Atopavo2020-07-03 Atopavo is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions
00372057001010 - Atopaderm Cream2020-03-02 Indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic der

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