TissueTak™ AS-19022TT

GUDID 07290017155357

Non-Sterile Sample of the TissueTak™ Permanent - 10 Permanent Fasteners Not for Human Use

VIA SURGICAL LTD

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 07290017155357
• NIH Device Record Key: 2521dc25-3c63-439b-9a14-f69ddab2532e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TissueTak™
• Version Model Number: AS-19022TT
• Catalog Number: AS-19022TT
• Company DUNS: 600319250
• Company Name: VIA SURGICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 20.9 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017155357 [Primary]
GS1	17290017155354 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203117

FDA Product Code

• GDW: Staple, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [TissueTak™]

• 17290017155347: Non-Sterile Sample of the TissueTak™ Absorbable - 10 Absorbable Fasteners Not for Human Use
• 17290017155309: TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners
• 07290017155357: Non-Sterile Sample of the TissueTak™ Permanent - 10 Permanent Fasteners Not for Human Use
• 07290017155364: TissueTak™ Absorbable Fixation System 10 Absorbable Fasteners Tendon Anchor Device in Rotator