Silagen 100% Pure Silicone Gel

GUDID 00816465020220

6130 Silagen Pure Silicone Gel, 1.0 oz. (30 gram), 1 bottle/package

Newmedical Technology, Inc.

Scar-management dressing, single-use

• Primary Device ID: 00816465020220
• NIH Device Record Key: c2cbee40-822e-4d5e-bf22-04c80f2ee11a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silagen 100% Pure Silicone Gel
• Version Model Number: 6130
• 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	00816465020220 [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

On-Brand Devices [Silagen 100% Pure Silicone Gel]

• 00816465020220: 6130 Silagen Pure Silicone Gel, 1.0 oz. (30 gram), 1 bottle/package
• 00816465020213: 6115 Silagen Pure Silicone Gel, 0.5oz. (15 gram), 1 bottle/package