DigiFix Sterile Kit

GUDID 00861988000334

Single use DigiFix Sterile Kit

VIRAK ORTHOPEDICS LLC

Orthopaedic bone wire

• Primary Device ID: 00861988000334
• NIH Device Record Key: d7385b2c-4413-4b09-981f-186cd8b8194d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigiFix Sterile Kit
• Version Model Number: 1146-STKT
• Company DUNS: 080520937
• Company Name: VIRAK ORTHOPEDICS LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861988000334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192465

FDA Product Code

• JEC: Component, Traction, Invasive

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: 2023-08-23
• Device Publish Date: 2023-08-15

Devices Manufactured by VIRAK ORTHOPEDICS LLC

• 00861988000334 - DigiFix Sterile Kit: 2023-08-23Single use DigiFix Sterile Kit
• 00861988000334 - DigiFix Sterile Kit: 2023-08-23 Single use DigiFix Sterile Kit
• 00861988000303 - DigiFix: 2018-07-06 .045" K-Wire
• 00861988000310 - DigiFix: 2018-07-06 .054" K-wire
• 00861988000327 - DigiFix: 2018-07-06 Bracket Assembly - 1146-3000