Silicone for Scar Management 701

GUDID G420701

Ensil Fabric, 8" x 8"

Gottfried Medical, Inc.

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• Primary Device ID: G420701
• NIH Device Record Key: 51381368-81f7-4dc8-b8b5-a09e0d941f10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone for Scar Management
• Version Model Number: 701
• Catalog Number: 701
• Company DUNS: 038706180
• Company Name: Gottfried Medical, Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G420701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010675

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: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [Silicone for Scar Management]

• G420710: Ensil Fabric, Linear Foot
• G420701: Ensil Fabric, 8" x 8"