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 Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial Skin osmotic dressing, non-antimicrobial

• Primary Device ID: 00860003521205
• NIH Device Record Key: 11d8e780-a053-4781-8823-d14646949510
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atopavo
• Version Model Number: 102-001
• Company DUNS: 081039213
• Company Name: ONPACE PHARMA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com
• Phone: (228)207-8112
• Email: sales@onpacepharma.com

Device Dimensions

• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram
• Weight: 45 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature, do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003521205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092878

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-03
• Device Publish Date: 2020-06-25

Devices Manufactured by ONPACE PHARMA LLC

• 00860003521205 - Atopavo: 2020-07-03Atopavo 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 - Atopavo: 2020-07-03 Atopavo is a water-based, non-sterile emulsion formulated for the dressing and management of superficial wounds, minor abrasions
• 00372057001010 - Atopaderm Cream: 2020-03-02 Indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic der