Neurolac TW ND02-025/03

GUDID 08717703990430

Polyganics Innovations B.V.

Nerve guide, synthetic-polymer, bioabsorbable

• Primary Device ID: 08717703990430
• NIH Device Record Key: 399088e4-5bbe-41a2-ab25-4949e386d5a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurolac TW
• Version Model Number: 2.5 mm
• Catalog Number: ND02-025/03
• 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
• 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
• 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
• 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

• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer
• Lumen/Inner Diameter: 2.5 Micrometer

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
• 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
• 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
• 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	08717703990430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112267

FDA Product Code

• JXI: Cuff, Nerve

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: 2024-03-05
• Device Publish Date: 2017-07-17

On-Brand Devices [Neurolac TW]

• 08717703990447: 3.0 mm
• 08717703990430: 2.5 mm
• 08717703990423: 2.0 mm
• 08717703990416: 1.5 mm