Atopaderm Cream

GUDID 00372057001010

Indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Atopaderm Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

ONPACE PHARMA LLC

Skin moisture barrier dressing

• Primary Device ID: 00372057001010
• NIH Device Record Key: e111de34-30e4-4d7a-9b1f-5878dcecf04f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atopaderm Cream
• Version Model Number: 101-001
• 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: true
• 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

Device Dimensions

• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372057001010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150914

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: 2020-03-02
• Device Publish Date: 2020-02-21

Devices Manufactured by ONPACE PHARMA LLC

• 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: 2020-03-02Indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Atopaderm Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
• 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