DigiFix 1146-3000

GUDID 00861988000327

Bracket Assembly - 1146-3000

VIRAK ORTHOPEDICS LLC

Orthopaedic bone wire

• Primary Device ID: 00861988000327
• NIH Device Record Key: 391a7911-0bcb-4714-b874-e1250748e5d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigiFix
• Version Model Number: 1146-0001
• Catalog Number: 1146-3000
• 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: false
• 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	00861988000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132731

FDA Product Code

• JEC: Component, Traction, Invasive

Sterilization

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

[00861988000327]

Moist Heat or Steam Sterilization

[00861988000327]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-02

On-Brand Devices [DigiFix]

• 00861988000327: Bracket Assembly - 1146-3000
• 00861988000310: .054" K-wire
• 00861988000303: .045" K-Wire