NeedleGuide

Basic Information

• Brand Name: NeedleGuide
• Primary DI: 10841436121993
• Version / Model: H44901AX
• Catalog Number: H44901AX, H44901AX-5
• 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: 2022-12-07
• Public Version: 3
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: e9a5499d-ffdd-4f50-8fc7-02679d6418e0

Device Description

Sterile endocavity needle guide with (3.5x20cm) latex cover (1) for use with GE Healthcare RIC10 transducers

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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	00841436121996	GS1		24	In Commercial Distribution
Primary	10841436121993	GS1
Package	00841436122009	GS1		5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970514	000

Storage Conditions

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