Precision GI 20GA Motorized EUS Biopsy Device

Basic Information

• Brand Name: Precision GI 20GA Motorized EUS Biopsy Device
• Primary DI: 07290019898009
• Version / Model: LMC-GI-20-01
• Catalog Number: LMC-GI-20-01
• Company Name: LIMACA MEDICAL LTD.
• Labeler DUNS: 532207419
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: 8e72f082-4abd-4e2e-b81a-efa3a2d3a713

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
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10403	Ultrasound aspiration biopsy procedure kit	A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019898009	GS1

Premarket Submissions

Submission Number	Supplement Number
K231422	000