FasTouch™ Absorbable FTAC10

GUDID 17290017155279

FasTouch™ Absorbable Reloadable Cartridge - 10 Absorbable Fasteners

VIA SURGICAL LTD

Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 17290017155279
• NIH Device Record Key: 38bdeb4a-6a53-4bff-b6c5-460e2b0a959b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FasTouch™ Absorbable
• Version Model Number: FTAC10
• Catalog Number: FTAC10
• 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

Customer Support Contacts

• Phone: +18009696331
• Email: CS@progressivemedinc.com

Device Dimensions

• Length: 37 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017155272 [Primary]
GS1	17290017155279 [Package]; Contains: 07290017155272; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181668

FDA Product Code

• GDW: Staple, Implantable

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: 2019-09-23
• Device Publish Date: 2019-09-14

On-Brand Devices [FasTouch™ Absorbable]

• 17290017155286: Sample of the FasTouch™ Absorbable Reloadable Cartridge - 10 Absorbable Fasteners
• 17290017155279: FasTouch™ Absorbable Reloadable Cartridge - 10 Absorbable Fasteners
• 17290017155248: Sample of the FasTouch™ Absorbable Fixation System - 25 Absorbable Fasteners
• 17290017155217: FasTouch™ Absorbable Fixation System - 25 Absorbable Fasteners