TIELLE® SILICONE BORDER TLSB0709EN

GUDID 25051978006050

Hydropolymer Dressing with Silicone

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound-nonadherent dressing, absorbent, sterile

• Primary Device ID: 25051978006050
• NIH Device Record Key: 87af2a4b-712f-4413-8ef2-65e983d82111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIELLE® SILICONE BORDER
• Version Model Number: TLSB0709EN
• Catalog Number: TLSB0709EN
• 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: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 Centimeter
• Width: 7 Centimeter
• Length: 9 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	15051978006053 [Primary]
GS1	25051978006050 [Package]; Contains: 15051978006053; Package: [10 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 [TIELLE® SILICONE BORDER]

• 25051978006050: Hydropolymer Dressing with Silicone
• 25051978005756: Hydropolymer Dressing with Silicone
• 25051978005725: Hydropolymer Dressing with Silicone
• 25051978005695: Hydropolymer Dressing with Silicone
• 25051978005657: Hydropolymer Dressing with Silicone