Precision GI 20GA Motorized EUS Biopsy Device LMC-GI-20-01

GUDID 07290019898009

LIMACA MEDICAL LTD.

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 07290019898009
• NIH Device Record Key: 8e72f082-4abd-4e2e-b81a-efa3a2d3a713
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision GI 20GA Motorized EUS Biopsy Device
• Version Model Number: LMC-GI-20-01
• Catalog Number: LMC-GI-20-01
• Company DUNS: 532207419
• Company Name: LIMACA MEDICAL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019898009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231422

FDA Product Code

• FCG: Biopsy Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-02
• Device Publish Date: 2023-10-25