Sterile Disposable Endocavity Needle Guide Kit

Basic Information

• Brand Name: Sterile Disposable Endocavity Needle Guide Kit
• Primary DI: 00841912105809
• Version / Model: 5159
• Catalog Number: 5159
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Labeler DUNS: 965417181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-31
• Public Version: 8
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: c2f4205d-24ae-4f4f-9f4d-1173bd540aec

Device Description

Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion EC3-10 & EN-10, Philips C9-4EC, Prosonic EC10R, Samsung Medison EV4-9/10ED, ER4-9/10ED, ED4-9, EVN4-9, EC4-9/10ED, EV4-9 & ER4-9, and Ultrasonix EC9-5/10 Ultrasound Transducers

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60608	Body-orifice ultrasound imaging transducer cover, basic	A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.	No	Active
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	10841912105806	GS1		24	In Commercial Distribution
Primary	00841912105809	GS1