Single use Surgical Optical Fiber

Basic Information

• Brand Name: Single use Surgical Optical Fiber
• Primary DI: 08033945938543
• Version / Model: EMP-FBX200BHS-C
• Company Name: QUANTA SYSTEM SPA
• Labeler DUNS: 436045833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-28
• Public Version: 3
• Public Version Date: 2021-05-07
• Public Version Status: Update
• Public Device Record Key: 6c0b4fed-359f-4c6a-ba2d-4ce201529b8f

Device Description

Single use Ball tip Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America.Gyrus ACMI, Inc.

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: 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
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	08033945938826	GS1	carton box	2	In Commercial Distribution
Package	08033945938680	GS1	carton box	5	In Commercial Distribution
Primary	08033945938543	GS1

Premarket Submissions

Submission Number	Supplement Number
K180158	000