Atopavo

Basic Information

• Brand Name: Atopavo
• Primary DI: 00860003521205
• Version / Model: 102-001
• Company Name: ONPACE PHARMA LLC
• Labeler DUNS: 081039213
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-25
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 11d8e780-a053-4781-8823-d14646949510
• Distribution End Date: 2022-07-06

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58133	Skin osmotic dressing, non-antimicrobial	A substance (e.g., ointment, cream, spray, impregnated material) intended to be topically applied to the skin (e.g., face, eyelids, extremities) and containing compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to expedite wound healing and skin re-epithelialization primarily through osmotic properties which absorb and retain water to create a moist environment; it does not include antimicrobial agents. It may be used to treat superficial and/or deep wounds (e.g., abrasions, lacerations, burns, surgical wounds, decubitus sores, ulcers). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003521205	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	45	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature, do not freeze.