NAVIGATION INSTRUMENTS

GUDID 00889095717181

3.5mm Tap, CT, GI1

GLOBUS MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00889095717181
• NIH Device Record Key: cdce2978-3a1c-4f41-a5e4-89e4dd6caf2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAVIGATION INSTRUMENTS
• Version Model Number: 682.906
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Outer Diameter: 3.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095717181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180690

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00889095717181]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-05
• Device Publish Date: 2019-06-27

On-Brand Devices [NAVIGATION INSTRUMENTS]

• 00889095174038: Pedicle Probe, Straight, GI1
• 00889095173840: Pedicle Probe Thoracic, Straight, GI1
• 00889095173819: Pedicle Probe, Straight, GI1
• 00889095717235: Drill Bit for 4.0mm Screw, CT, GI1
• 00889095717228: Drill Bit for 3.5mm Screw, CT, GI1
• 00889095717211: Screwdriver, 2.5mm Hex, Self Retaining, CT, GI1
• 00889095717204: ELLIPSE Polyaxial Screwdriver, CT, GI1
• 00889095717198: 4.0mm Tap, CT, GI1
• 00889095717181: 3.5mm Tap, CT, GI1
• 00889095174137: 9.5mm Cannulated Tap, GI1
• 00889095174069: 10.5mm Cannulated Tap, GI1
• 00889095174052: 4.0mm Tap, GI1
• 00889095174045: 3.5mm Tap, GI1
• 00889095173970: 8.5mm Cannulated Tap, GI1
• 00889095173963: 7.5mm Cannulated Tap, GI1
• 00889095173956: 6.5mm Cannulated Tap, GI1
• 00889095173949: 5.5mm Cannulated Tap, GI1
• 00889095173932: 5.0mm Cannulated Tap, GI1
• 00889095173901: 8.5mm Tap, GI1
• 00889095173895: 7.5mm Tap, GI1
• 00889095173888: 6.5mm Tap, GI1
• 00889095173871: 5.5mm Tap, GI1
• 00889095173864: 5.0mm Tap, GI1
• 00889095173857: 4.5mm Tap, GI1