GSO ACP1 Spinal System

GUDID M9935097240

Fixed Drill Guide

GOLD STANDARD ORTHOPEDICS, LLC

Surgical drill guide, reusable

• Primary Device ID: M9935097240
• NIH Device Record Key: 4776a2bb-f1b4-4d50-84ae-0bac37cc94d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSO ACP1 Spinal System
• Version Model Number: 509724
• 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	M9935097240 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

Moist Heat or Steam Sterilization

[M9935097240]

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 ACP1 Spinal System]

• M9935097240: Fixed Drill Guide
• M9935097230: Variable Drill Guide
• M9935097120: Screw Holder
• M9935097280: Plate Holder
• M9935097220: Awl