TIELLE® PACKING MT2450

GUDID 25051978000539

Hydropolymer Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Cavity-wound management dressing

• Primary Device ID: 25051978000539
• NIH Device Record Key: 35820582-a2b3-491d-9a2e-7a2448391472
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIELLE® PACKING
• Version Model Number: MT2450
• Catalog Number: MT2450
• 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: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 Centimeter
• Width: 9.5 Centimeter
• Length: 9.5 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	15051978000532 [Primary]
GS1	25051978000539 [Package]; Contains: 15051978000532; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-09-24

Devices Manufactured by SYSTAGENIX WOUND MANAGEMENT, LIMITED

• 25051978000539 - TIELLE® PACKING: 2020-05-06Hydropolymer Dressing
• 25051978000539 - TIELLE® PACKING: 2020-05-06 Hydropolymer Dressing
• 25051978001086 - FIBRACOL® PLUS: 2020-05-06 Collagen Wound Dressing with Alginate
• 25051978001093 - FIBRACOL® PLUS: 2020-05-06 Collagen Wound Dressing with Alginate
• 25051978001109 - FIBRACOL® PLUS: 2020-05-06 Collagen Wound Dressing with Alginate
• 25051978001116 - FIBRACOL® PLUS: 2020-05-06 Collagen Wound Dressing with Alginate
• 25051978002830 - PROMOGRAN PRISMA®: 2020-01-10 Matrix
• 25051978002885 - PROMOGRAN PRISMA®: 2020-01-10 Matrix
• 25051978009990 - PROMOGRAN PRISMA®: 2020-01-10 Matrix