Gangi-HydroGuard Coaxial Needle

Basic Information

• Brand Name: Gangi-HydroGuard Coaxial Needle
• Primary DI: 07350031351361
• Version / Model: HG17-171
• Catalog Number: HG17-171
• Company Name: Apriomed AB
• Labeler DUNS: 631734758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-21
• Public Version: 8
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: edc43e5f-528f-401d-b2a5-cb2f35bb6b63
• Distribution End Date: 2026-02-26

Device Description

Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 17G x 17.1cm.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	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	27350031351365	GS1	Transportation box	12	In Commercial Distribution	2026-02-26
Package	17350031351368	GS1	Shelf box	5	Not in Commercial Distribution	2026-02-26
Primary	07350031351361	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181756	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	17	Gauge
Length	17.1	Centimeter