LiNA OperaScope™ Scissors

Basic Information

• Brand Name: LiNA OperaScope™ Scissors
• Primary DI: 05708265011490
• Version / Model: OP-SCI-3
• Catalog Number: OP-SCI-3
• Company Name: Lina Medical ApS
• Labeler DUNS: 305088619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 1
• Public Version Date: 2019-07-08
• Public Version Status: New
• Public Device Record Key: 22ee4d0d-732e-43bc-9f87-c33a7223c8a1

Device Description

Scissors for hysteroscopy.

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: Yes
• 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
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	884.1690	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
Package	05708265011506	GS1		3	In Commercial Distribution
Primary	05708265011490	GS1

Customer Contacts

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