GSO PCT Spinal System

GUDID M9935071550

Drill Guide

GOLD STANDARD ORTHOPEDICS, LLC

Surgical drill guide, reusable

• Primary Device ID: M9935071550
• NIH Device Record Key: 834cde20-74ea-457e-a40f-80ff753214ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSO PCT Spinal System
• Version Model Number: 507155
• Company DUNS: 028008203
• Company Name: GOLD STANDARD ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9935071550 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

[M9935071550]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-06
• Device Publish Date: 2018-09-21

On-Brand Devices [GSO PCT Spinal System]

• M9935071630: Rod Holder
• M993507155120: 12mm Drill Guide Extension
• M9935071550: Drill Guide
• M9935071810: Instrument Case
• M9935071800: Implant Instrument Case
• M9935071540: Bone Awl Assembly
• M9935071600: Bone Screw Tap
• M9935071590: Bone Screw Tap
• M9935071580: Bone Screw Tap