Vivosorb FS01-006/20

GUDID 08717703990195

Polyganics Innovations B.V.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 08717703990195
• NIH Device Record Key: fcd858a3-9ae9-4585-8053-78cb3ab64a41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivosorb
• Version Model Number: 2x3cm
• Catalog Number: FS01-006/20
• Company DUNS: 489946080
• Company Name: Polyganics Innovations B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com
• Phone: +31505886598
• Email: b.ijmker@polyganics.com

Device Dimensions

• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter
• Width: 3 Centimeter
• Length: 2 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717703990195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042811

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-21
• Device Publish Date: 2015-09-21

On-Brand Devices [Vivosorb]

• 08717703990324: 12x17 cm
• 08717703990218: 10x13 cm
• 08717703990201: 5x7 cm
• 08717703990195: 2x3cm