1300XSB

Basic Information

• Brand Name: 1300XSB
• Primary DI: 00852350007006
• Version / Model: 1300XSB
• Catalog Number: 03-1300XSB
• Company Name: ISOLUX LLC
• Labeler DUNS: 828730973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-01
• Public Version: 5
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: f61010eb-05d9-4be9-894a-9426a2b6d8af
• Distribution End Date: 2026-12-31

Device Description

300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35158	Endoscopic light source unit, line-powered	A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852350007006	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K022384	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius