Large Pedicle Sounder

Basic Information

• Brand Name: Large Pedicle Sounder
• Primary DI: 00810097803503
• Version / Model: 101-0035
• Catalog Number: 101-0035
• Company Name: Osteocentric Technologies, Inc.
• Labeler DUNS: 089645059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-05
• Public Version: 2
• Public Version Date: 2025-01-15
• Public Version Status: Update
• Public Device Record Key: 9fe1d9a1-2538-4df6-b0d8-27f418ccaf4f

Device Description

Large Pedicle Sounder

Device Characteristics

• Single Use: Yes
• 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: No
• 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
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65866	Pedicle screw guide	A thin metal rod intended to guide the implantation of a pedicle screw during a minimally-invasive procedure, where it can also function as a guide for a gauge to provide a screw length measurement. It is inserted into the pedicle of a vertebra so that a cannulated pedicle screw is advanced over the guide, after a gauge is used over the guide to provide a measurement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810097803503	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221332	000