ADAPTIC TOUCH™ 500504

GUDID 35051978004145

Non-Adhering Silicone Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound-nonadherent dressing, permeable

• Primary Device ID: 35051978004145
• NIH Device Record Key: a6960251-af68-4e71-a5a5-3b64d6d6f734
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAPTIC TOUCH™
• Version Model Number: 500504
• Catalog Number: 500504
• Company DUNS: 211352227
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter
• Width: 20 Centimeter
• Length: 32 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978004141 [Primary]
GS1	35051978004145 [Package]; Contains: 15051978004141; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• NAD: Dressing, Wound, Occlusive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [ADAPTIC TOUCH™]

• 35051978004145: Non-Adhering Silicone Dressing
• 25051978004131: Non-Adhering Silicone Dressing
• 25051978004124: Non-Adhering Silicone Dressing
• 25051978004117: Non-Adhering Silicone Dressing