EPI-FOAM EPFU-W6

GUDID 00854763005549

Uncoated Epifoam Adhesive Wrap (6 wraps per case) 36"x 11.75"x 0.375"

BIODERMIS CORPORATION

Scar management dressing, reusable

• Primary Device ID: 00854763005549
• NIH Device Record Key: 1a46741d-bb43-49b8-ae1f-838440554bfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPI-FOAM
• Version Model Number: EPFU-W6
• Catalog Number: EPFU-W6
• 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

Customer Support Contacts

• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com
• Phone: 702-260-4466
• Email: info@biodermis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854763005549 [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 [EPI-FOAM]

• 00854763005792: Uncoated Epifoam Adhesive Wrap (1 wrap) 36"x 11.75"x 0.375"
• 00854763005785: Epifoam Adhesive Wrap (6 sheets per case) 36"x 11.75"x 0.375"
• 00854763005778: Epifoam Adhesive Wrap (1 Wrap ) 36"x 11.75"x 0.375"
• 00854763005761: EpIfoam Silicone-Backed Adhesive Pad (1 pad per pouch)
• 00854763005754: Epifoam Uncoated Pads (1 pad per pouch).
• 00854763005549: Uncoated Epifoam Adhesive Wrap (6 wraps per case) 36"x 11.75"x 0.375"
• 00854763005532: Epifoam Uncoated Pads (30 pads per case).
• 00854763005525: Epifoam Uncoated Pads (3 pads per pouch)