GSO PCT Spinal System

Basic Information

• Brand Name: GSO PCT Spinal System
• Primary DI: M9935071500
• Version / Model: 507150
• 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: 4
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: 069b222b-b4e4-4a3e-a69f-a0ae84fc08f2

Device Description

Straight Sounding Probe

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
HXB	Probe	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47862	Abdominal/ENT/orthopaedic surgical probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M9935071500	HIBCC

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Straight Sounding Probe