Needle Guide

Basic Information

• Brand Name: Needle Guide
• Primary DI: 10841436122860
• Version / Model: 610-1550
• Catalog Number: 610-1550
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-03
• Public Version: 1
• Public Version Date: 2023-05-11
• Public Version Status: New
• Public Device Record Key: 53fabc81-1f13-4323-9955-ae26e8081a82

Device Description

Sterile TP Pivot Pro™ transperineal needle guide

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, imaging, pulsed echo, ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65809	Percutaneous non-endoscopic instrument access cannula	A hollow slender tubular instrument designed for percutaneous insertion to provide access for instruments (e.g., biopsy needle) under radiological image guidance [e.g., ultrasound] during procedures relating to tissue lesions (e.g., biopsy, ablation). The cannula includes a sharp trocar blade/mandrel to assist introduction and is intended for soft tissue access, however it might additionally be intended for non-impactive bone access. It is not a dedicated bone access cannula and is not an endoscopic (laparoscopic, arthroscopic) access cannula. Some types include a guide to help percutaneous insertion (e.g., during transperineal prostate biopsy). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00841436122863	GS1		5	In Commercial Distribution
Primary	10841436122860	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K875236	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight