Single Use Surgical Optical Fiber

Basic Information

• Brand Name: Single Use Surgical Optical Fiber
• Primary DI: 08033945937256
• Version / Model: 09-0050
• Company Name: QUANTA SYSTEM SPA
• Labeler DUNS: 436045833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-05
• Public Version: 6
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: 8c28079f-ec0a-4d90-9f1b-ad35b892ef25
• Distribution End Date: 2023-06-15

Device Description

Single Use Surgical Optical Fiber ø 365 µm Distributed by Cogentix.

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: 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47785	Urogenital surgical laser system beam guide, single-use	A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08033945937461	GS1	carton box	2	Not in Commercial Distribution	2023-06-15
Package	08033945937362	GS1	carton box	5	Not in Commercial Distribution	2023-06-15
Primary	08033945937256	GS1