E-GPS Navigated Instrument System 75-RF-1555

GUDID 00840019970686

Tap, Reform, Cannulated, 5.5mm

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019970686
• NIH Device Record Key: 9af04803-9123-4ddf-9b36-becdb100932e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-GPS Navigated Instrument System
• Version Model Number: 75-RF-1555
• Catalog Number: 75-RF-1555
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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	00840019970686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220862

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

[00840019970686]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-12
• Device Publish Date: 2024-01-04

On-Brand Devices [E-GPS Navigated Instrument System]

• 00840019970761: Simulated Screwdriver
• 00840019970754: Modular Driver, Reform Ti, Cannulated
• 00840019970747: Locking MIS Driver, Reform Ti, Cannulated
• 00840019970730: Locking Polyaxial Driver, Reform Ti, Cannulated
• 00840019970723: Tap, Reform, Cannulated, 9.5mm
• 00840019970716: Tap, Reform, Cannulated, 8.5mm
• 00840019970709: Tap, Reform, Cannulated, 7.5mm
• 00840019970693: Tap, Reform, Cannulated, 6.5mm
• 00840019970686: Tap, Reform, Cannulated, 5.5mm