GSO GS1 Spinal System

Basic Information

• Brand Name: GSO GS1 Spinal System
• Primary DI: M9935081230
• Version / Model: 508123
• Company Name: UNIFIED SPINE, LLC
• Labeler DUNS: 118413370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 3
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: d74f8cdc-4e95-49f7-a55b-ccd5fce8afea

Device Description

Calipers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTZ	Caliper	Orthopedic	888.4150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35788	Orthopaedic bone calliper	A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M9935081230	HIBCC

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Calipers