DERMASOF DSG-TNT-123

GUDID 00852260000746

TNT Patch 2" x 2.5". 1 Pair

BIODERMIS CORPORATION

Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable

• Primary Device ID: 00852260000746
• NIH Device Record Key: 3841e22a-7ba8-448b-a468-11fad644aa0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMASOF
• Version Model Number: DSG-TNT-123
• Catalog Number: DSG-TNT-123
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852260000746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003948

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 [DERMASOF]

• 00854763005501: Mini Single sheet 5.7" x 2.5". 5 Sheets
• 00854763005495: Square sheet 3" x 2.5". 5 Sheets
• 00854763005242: Mini Single sheet 5.7" x 2.5". 1 Sheet
• 00854763005235: Square sheet 3" x 2.5". 1 Sheet
• 00852260000968: DermaSof Silicone Stick 4.25g tube.
• 00852260000951: Areopexy, 2.75" OD x .75 ID x 5.90" L, 1 Pair
• 00852260000852: Areola Circles 3" x .75", 1 Pair
• 00852260000845: TNT Areola Circle 3" x .75", 1 Pair
• 00852260000838: Mastopexy-L/R 12.6" x 3.8", 1 pair
• 00852260000821: TNT Mastopexy-L/R 12.6" x 3.8". 1 Pair
• 00852260000814: Strip 1.4" x 11.5". 1 Pair
• 00852260000807: Large sheet 11" x 15.75". 1 Sheet
• 00852260000791: Patch 2"x 2.5". 1 Pair
• 00852260000784: Standard sheet 4.7" x 5.7". 1 Sheet
• 00852260000777: Standard sheet 4.7" x 5.7". 5 Sheets
• 00852260000760: TNT Strip 1.4" x 11.5". 1 Pair
• 00852260000753: TNT Large sheet 11" x 15.75. 1 Sheet
• 00852260000746: TNT Patch 2" x 2.5". 1 Pair
• 00852260000739: Standard sheet 4.7" x 5.7". 1 Sheet
• 00852260000722: TNT Standard sheet 4.7" x 5.7". 5 Sheets