EPIFOAM EPF-30

GUDID 00852260000432

Epifoam Adhesive Pads (30 pads per case) 7.75"x 11.5"x 0.5"

BIODERMIS CORPORATION

Scar management dressing, reusable

• Primary Device ID: 00852260000432
• NIH Device Record Key: 4783b671-84be-46c2-8bf1-bbb74b0909f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIFOAM
• Version Model Number: EPF-30
• Catalog Number: EPF-30
• Company DUNS: 809650005
• Company Name: BIODERMIS CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852260000432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991604

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

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: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [EPIFOAM]

• 00852260000869: Epifoam Adhesive Pads (3 pads per pouch) 7.75"x 11.5"x 0.5"
• 00852260000432: Epifoam Adhesive Pads (30 pads per case) 7.75"x 11.5"x 0.5"