GSO GS1 Spinal System

GUDID M993507155140

14mm Drill Guide Extension

GOLD STANDARD ORTHOPEDICS, LLC

Surgical drill guide, reusable

• Primary Device ID: M993507155140
• NIH Device Record Key: 2b642b3f-a941-4f40-9c79-10386275eb4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GSO GS1 Spinal System
• Version Model Number: 50715514
• 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	M993507155140 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

Moist Heat or Steam Sterilization

[M993507155140]

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 GS1 Spinal System]

• M9935081510: Inserter
• M9935042640: Nav Compatible Bone Tap W/1/4" Quick Connect 7.0mm Bone Tap
• M9935042630: Nav Compatible Bone Tap W/1/4" Quick Connect 6.25mm Bone Tap
• M9935042620: Nav Compatible Bone Tap W/1/4" Quick Connect 5.5mm Bone Tap
• M9935042230: Nav Compatible Probe
• M9935041630: Navigation Screw Inserter Assembly
• M9935082110: Rod Holder Fixed
• M993507155140: 14mm Drill Guide Extension
• M9935042110: Rod Holder
• M9935041710: Hook Holder
• M9935082030: Implant Case
• M9935082020: Screw Caddy
• M9935082010: Instrument Case
• M9935042030: Instrument Case
• M9935042020: Instrument Case
• M9935042010: Implant Case
• M9935041700: Hook Implant Instrument Case
• M9935082460: Cannulated Awl
• M9935042060: Bone Awl
• M9935082430: Cannulated Bone Tap With 1/4" Square QC
• M9935082420: Cannulated Bone Tap With 1/4" Square QC
• M9935042420: Bone Tap With 1/4" Square QC
• M9935042140: Bone Tap
• M9935042130: Bone Tap
• M9935042120: Bone Tap