TIELLE® LITE MTL301EN

GUDID 25051978003318

Hydropolymer Adhesive Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound-nonadherent dressing, absorbent, sterile

• Primary Device ID: 25051978003318
• NIH Device Record Key: c95c7ee3-8c94-4ee8-bbc8-22c046a9cdc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIELLE® LITE
• Version Model Number: MTL301EN
• Catalog Number: MTL301EN
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter
• Width: 11 Centimeter
• Length: 11 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978003311 [Primary]
GS1	25051978003318 [Package]; Contains: 15051978003311; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

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 [TIELLE® LITE]

• 25051978005626: Hydropolymer Adhesive Dressing
• 25051978003318: Hydropolymer Adhesive Dressing
• 25051978003301: Hydropolymer Adhesive Dressing
• 25051978000720: Hydropolymer Adhesive Dressing
• 25051978000706: Hydropolymer Adhesive Dressing