Leapmed

Basic Information

• Brand Name: Leapmed
• Primary DI: 06941165063575
• Version / Model: 28-CN17GT
• Catalog Number: 28-CN17GT
• Company Name: Suzhou Leapmed Healthcare Corporation
• Labeler DUNS: 544411637
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-01
• Public Version: 1
• Public Version Date: 2026-04-09
• Public Version Status: New
• Public Device Record Key: 0768cba0-9e87-4c66-97d1-f3902d41f126

Device Description

Disposable Coaxial Biopsy Needle, 16G×12.0cm

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: 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
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16941165063572	GS1		10	In Commercial Distribution
Primary	06941165063575	GS1
Package	26941165063579	GS1		14	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K212822	000