Aladerm Plus

GUDID 00328595282022

Topical skin care emulsion

Allegis Pharmaceuticals, LLC

Skin osmotic dressing, non-antimicrobial

• Primary Device ID: 00328595282022
• NIH Device Record Key: c1582baf-e5dd-436d-8bcc-c113e65a8efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aladerm Plus
• Version Model Number: 282
• Company DUNS: 792272861
• Company Name: Allegis Pharmaceuticals, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• 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: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com
• Phone: +1(601)859-0038
• Email: rcrowder@allegispharma.com

Device Dimensions

• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter
• Total Volume: 60 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00328595282022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141637

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: 2022-02-17
• Device Publish Date: 2022-02-09