CoLink View

GUDID 00817906027907

Tranverse Drill Guide Assembly, 3.5 Screw

IN2BONES USA, LLC

Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool

• Primary Device ID: 00817906027907
• NIH Device Record Key: 5d58b8ad-35fa-4625-bc58-03ae906789ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLink View
• Version Model Number: P04 N0191
• Company DUNS: 079700711
• Company Name: IN2BONES USA, 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: false
• 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	00817906027907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172300

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00817906027907]

Moist Heat or Steam Sterilization

[00817906027907]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [CoLink View]

• 00817906027907: Tranverse Drill Guide Assembly, 3.5 Screw
• 00817906027891: Insert Driver, Assy