Ultra-Pro II™ Needle Guide

Basic Information

• Brand Name: Ultra-Pro II™ Needle Guide
• Primary DI: 10841436102459
• Version / Model: 610-1213, 610-1213-5
• Catalog Number: 610-1213, 610-1213-5
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-22
• Public Version: 10
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: bc052d99-afcb-473c-93ca-2612bc622f63
• Distribution End Date: 2020-12-17

Device Description

Sterile needle guide with (14 x 29.2cm) telescopically folded CIV-Flex™ wireless transducer cover

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00841436102445	GS1		5	Not in Commercial Distribution	2020-12-17
Package	00841436102452	GS1		24	Not in Commercial Distribution	2020-12-17
Primary	10841436102459	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093713	000

Device Sizes

Type	Value	Unit	Text
Length	1.6	Inch
Height	1.3	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight
• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit