LiNA OperaScope™ Tubing & Drape kit

Basic Information

• Brand Name: LiNA OperaScope™ Tubing & Drape kit
• Primary DI: 05708265012480
• 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: 2020-09-04
• Public Version: 2
• Public Version Date: 2020-10-15
• Public Version Status: Update
• Public Device Record Key: 92c49a87-bed8-44a0-892b-99d7bc419061

Device Description

Tubing & drape Kit intended for hysteroscopy and cystoscopy

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
PXU	Fluid Drainage Tray	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65103	Hysteroscopic/cystoscopic distention tubing set	A collection of noninvasive, flexible, polymer tube segments with associated items (e.g., connectors, drainage bag, drape) intended to be used with an appropriate endoscope (hysteroscope, cystoscope) to manage the inflow and outflow of distension fluids during diagnostic and operative endoscopy of the uterine cavity and urinary bladder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708265012480	GS1

Customer Contacts

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