Endoch

Basic Information

• Brand Name: Endoch
• Primary DI: EAI0812
• Version / Model: EAI-0812
• Catalog Number: EAI-0812
• Company Name: Endoch Inc
• Labeler DUNS: 241382683
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-01
• Public Version: 1
• Public Version Date: 2019-06-10
• Public Version Status: New
• Public Device Record Key: 1e3db616-889c-46be-9509-5a1e047dd801

Device Description

DISPOSABLE LAPAROSCOPIC METZBAUM SCISSORS, CURVED, HEAVY BLADES, PATTERN

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2
JOK	Scissors, Medical, Disposable	General Hospital	880.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63163	Rigid endoscopic scissors, single-use	A sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EAI0812	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K171825	000