EPI-DERM CDG-P30

GUDID 00852260000258

Camo Pink, 30 Sheets 2.75" x 1.18". (7 cm x 3 cm), 30 Sheets.

BIODERMIS CORPORATION

Scar management dressing, reusable

• Primary Device ID: 00852260000258
• NIH Device Record Key: 47ba052f-234f-41b2-8609-d4eb617b44e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPI-DERM
• Version Model Number: CDG-P30
• Catalog Number: CDG-P30
• 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	00852260000258 [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 [EPI-DERM]

• 00854763005877: Natural Fabric Standard sheet 4.7" x 5.7", 6 Sheets
• 00854763005860: TNT Standard sheet 4.7" x 5.7", 6 Sheets
• 00854763005006: Fabric Backed Silicone Strip 1.4" x 6.0". 2 Strips
• 00852260000944: Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 Pair
• 00852260000937: Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair
• 00852260000920: TNT EpiTab Squares 30-Pack 1.25" x 1.25" (3 x 3 cm)
• 00852260000913: TNT EpiTab Circles 30-Pack 1.90 cm Diam
• 00852260000906: TNT Areopexy 2.75" OD x .75 ID x 5.90", 5 Pair
• 00852260000890: TNT Areopexy 2.75" OD x .75 ID x 5.90", 1 Pair
• 00852260000876: Natural Fabric Mastopexy-L/R 12.6" x 3.8" (32. x 9.63 cm). 5 Pair
• 00852260000715: Areola Circles 3" x .75" (7.60 x 1.90 cm). 1 Pair
• 00852260000708: Areola Circles 3" x .75" (7.60 x 1.90 cm). 5 Pair
• 00852260000692: TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 1 Pair
• 00852260000685: TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 5 Pair
• 00852260000678: C-Strip 1.4" x 6.0" (3.6 x 15 cm). 1 C-Strip
• 00852260000661: Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair
• 00852260000654: Large sheet 11" x 15.75" (28 x 40 cm). 1 Sheet
• 00852260000647: Patch 2 x 2.5 in. (5 x 6 cm). 1 Pair
• 00852260000630: Standard sheet 4.7 x 5.7 in. (12 x 14.5 cm). 1 Sheet
• 00852260000623: Standard sheet 4.7 x 5.7 in. (12 x 14.5 cm). 5 Sheets
• 00852260000616: C-Strip 1.4" x 6.0" (3.6 x 15 cm). 5 C-Strips
• 00852260000609: Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair
• 00852260000593: Large sheet 11" x 15.75" (28 x 40 cm). 5 Sheets
• 00852260000586: Patch 2 x 2.5 in. (5 x 6 cm). 5 Pair
• 00852260000579: TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 1 C-Strip
• 00852260000562: TNT, Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm) , 1 Pair
• 00852260000555: TNT Large Sheet, 11" x 15.75" (28 x 40 x 0.09cm), 1 Large Sheet
• 00852260000548: TNT Patch, 2" x 2.5", (5.0 x 6.0 x 0.09cm), 1 Pair
• 00852260000531: TNT Standard Sheet, 4.7" x 5.7", (12 x 14.5 x 0.09cm), 1 Sheet
• 00852260000524: TNT Standard Sheet, 4.5" x 5.7", (12 x 14.5 x 0.09cm), 5 Pack
• 00852260000517: TNT C-Strip, 1.4" x 6.0", (3.6 x 15 x 0.09cm), 5 Pack
• 00852260000500: TNT Strip, 1.4" x 11.5", (3.60 x 29.0 x 0.09cm), 5 Pack
• 00852260000494: TNT Large Sheet, 11" x 15.75", (28 x 40 x 0.09cm), 5 Pack
• 00852260000487: TNT, Patch 2" x 2.5", (5.0 x 6.0 x 0.09cm), 5 Pack
• 00852260000470: Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 1 Pair
• 00852260000463: Mastopexy-L/R 12.6 x 3.8 in. (32. x 9.63 cm). 5 Pair
• 00852260000456: TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 1 Pair
• 00852260000449: TNT Mastopexy-L/R 12.6" x 3.8", (32 x 9.63 x 0.09 cm), 5 Pair
• 00852260000425: Natural Fabric Areola Circles 3" x .75". (7.60 x 1.90cm). 1 Pair
• 00852260000418: Natural Fabric Areola Circles 3" x .75" (7.60 x 1.90cm). 5 Pair
• 00852260000401: Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 1 C-Strip
• 00852260000395: Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 1 Pair
• 00852260000388: Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 1 Large Sheet
• 00852260000371: Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 1 Pair
• 00852260000364: Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 1 Sheet
• 00852260000357: Natural Fabric Standard sheet 4.7" x 5.7" (12 x 14.5 cm). 5 Sheets
• 00852260000340: Natural Fabric C-Strip 1.4" x 6.0" (3.6 x 15 cm), 5 C-Strips
• 00852260000333: Natural Fabric Strip 1.4" x 11.5" (3.6 x 29 cm) 5 Pair
• 00852260000326: Natural Fabric Large sheet 11" x 15.25" (28 x 39 cm). 5 Large Sheets
• 00852260000319: Natural Fabric Patch 2" x 2.5" (5 x 6 cm). 5 Pair