NewGel+UV Silicone Gel for Scars + SPF30

GUDID 00816465020046

8015 NewGel+UV Silicone Gel, 0.5 oz. (15 gram), 1 tube/package

Newmedical Technology, Inc.

Scar-management dressing, single-use

• Primary Device ID: 00816465020046
• NIH Device Record Key: 94ef6c25-b646-45bc-975e-2c6880e4d467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NewGel+UV Silicone Gel for Scars + SPF30
• Version Model Number: 8015
• Company DUNS: 787828669
• Company Name: Newmedical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: false

Customer Support Contacts

• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com
• Phone: 847-412-1000
• Email: regulatory@newmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816465020046 [Primary]

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: 2025-08-15
• Device Publish Date: 2025-08-07

Devices Manufactured by Newmedical Technology, Inc.

• 00816465020008 - NewGel+ Silicone Gel Sheeting: 2025-08-15 NG-365 NewGel+ Clear Silicone Abdomen Sheet, 2"x8" (5.1 x20.3cm), 1 pc/package
• 00816465020015 - NewGel+ Silicone Gel Sheeting: 2025-08-15 NG-165 NewGel+ Beige Silicone Abdomen Sheet, 2"x8"(5.1 x20.3cm), 1 pc/package
• 00816465020046 - NewGel+UV Silicone Gel for Scars + SPF30: 2025-08-158015 NewGel+UV Silicone Gel, 0.5 oz. (15 gram), 1 tube/package
• 00816465020046 - NewGel+UV Silicone Gel for Scars + SPF30: 2025-08-15 8015 NewGel+UV Silicone Gel, 0.5 oz. (15 gram), 1 tube/package
• 00816465020213 - Silagen 100% Pure Silicone Gel: 2025-08-15 6115 Silagen Pure Silicone Gel, 0.5oz. (15 gram), 1 bottle/package
• 00816465020220 - Silagen 100% Pure Silicone Gel: 2025-08-15 6130 Silagen Pure Silicone Gel, 1.0 oz. (30 gram), 1 bottle/package
• 00816465020237 - Silagen Silicone Gel for Scars + SPF30 UV Protection: 2025-08-15 6230 Silagen Silicone Gel + SPF30, 1.0oz. (30 gram), 1 bottle/package
• 00816465020244 - Silagen Silicone Gel for Scars + SPF30 UV Protection: 2025-08-15 6215 Silagen Silicone Gel + SPF30, 0.5oz. (15 gram), 1 bottle/package
• 00816465020299 - NewGel+E Advanced Silicone Gel for Scars: 2025-08-15 NGO-810 NewGel+E Silicone Gel, 1.0 oz. (30 gram), 1 tube/package