LiNA OperaScope™ Tubing & Drape kit

Basic Information

• Brand Name: LiNA OperaScope™ Tubing & Drape kit
• Primary DI: 05708265010585
• Version / Model: OP-TDK-6
• Catalog Number: OP-TDK-6
• Company Name: Lina Medical ApS
• Labeler DUNS: 305088619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-11
• Public Version: 4
• Public Version Date: 2019-04-09
• Public Version Status: Update
• Public Device Record Key: 8e920fc9-30f6-42ea-a082-10d67e271f15

Device Description

Tubing & drape 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
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	884.1700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60644	Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708265010592	GS1		6	In Commercial Distribution
Primary	05708265010585	GS1

Customer Contacts

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