TIELLE® SILICONE BORDER TLSB1212EN

GUDID 25051978005695

Hydropolymer Dressing with Silicone

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound-nonadherent dressing, absorbent, sterile

• Primary Device ID: 25051978005695
• NIH Device Record Key: 0a10ecf4-cab5-4c08-8521-5eb404dea97b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIELLE® SILICONE BORDER
• Version Model Number: TLSB1212EN
• Catalog Number: TLSB1212EN
• 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: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 Centimeter
• Width: 12.5 Centimeter
• Length: 12.5 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	15051978005698 [Primary]
GS1	25051978005695 [Package]; Contains: 15051978005698; 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