LAGIS

Basic Information

• Brand Name: LAGIS
• Primary DI: 04714123022431
• Version / Model: DI-5901-45D
• Catalog Number: DI-5901-45D
• Company Name: LAGIS ENTERPRISE CO., LTD.
• Labeler DUNS: 656417933
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-02
• Public Version: 1
• Public Version Date: 2024-12-10
• Public Version Status: New
• Public Device Record Key: 313aedcc-8606-497f-bf9d-5541f839ea01

Device Description

5mm x 450 mm Babcock Grasping Forceps, Double Action 5mm x 450 mm Babcock Grasping Forceps, Double Action

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: Yes
• 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: 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04714123022431	GS1

Customer Contacts

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