LF

GUDID 10746190002468

Direct Digital Urology Imaging System, 64kW

LIEBEL-FLARSHEIM COMPANY LLC

Stationary uro-gynaecological fluoroscopic x-ray system, digital

• Primary Device ID: 10746190002468
• NIH Device Record Key: 051dc9db-bef2-4cf7-9372-95889f533e07
• Commercial Distribution Discontinuation: 2019-10-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LF
• Version Model Number: 700559
• Company DUNS: 152760567
• Company Name: LIEBEL-FLARSHEIM COMPANY LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10746190002468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121838

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-07-10
• Device Publish Date: 2016-09-09

On-Brand Devices [LF]

• 10746190002093: Tubing with Male Luer Adapter (High Pressure)
• 20746190002083: Tubing with Male Luer Adapter (High Pressure)
• 30746190002059: Tubing with Male Luer Adapter (Low Pressure)
• 10746190002871: OptiStar Elite MR Contrast Delivery System
• 10746190002475: Direct Digital Urology Imaging System, 80 kW
• 10746190002468: Direct Digital Urology Imaging System, 64kW
• 10746190002451: Hydra Vision Urology System, 80 kW
• 10746190002444: Hydra Vision Urology System, 64kW
• 10746190002017: Angio / CT Syringe with Handi-Fil Straw; fits injectors: OptiStat and Angiomat 6000
• 20746190004278: Angiographic Syringe with Filling Spike; for use with Illumena Neo and Angiomat Illumena
• 10746190004325: OptiOne Single-Head CT Contrast Delivery System
• 10746190004318: OptiOne Single-Head Contrast Delivery System
• 10746190004967: Illumena, Pedestal Assembly (Accessory)
• 10746190004950: Illumena, Pedestal Assembly (Accessory)
• 10746190004820: OptiVantage/OptiOne, Remote Stand (Accessory)
• 10746190004776: OptiStar Elite, Fixed Height Stand Assembly (Accessory)
• 10746190004707: Illumena, Remote Stand (Accessory)
• 20746190002397: Drain Bag - use with Hydra Vision or Direct Digital Urology Systems
• 20746190002380: Drain Bag used with Hydra Vision or Direct Digital Urology Systems
• 10746190005070: Illumena Neo Contrast Delivery System, Console Wall Mount (Accessory)
• 10746190005032: Illumena Neo Contrast Delivery System, Table Mount (Accessory)
• 10746190005001: Illumena Neo Contrast Delivery System, U.S. Table Mount Injector Assy (USA; Accessory)
• 10746190004998: Illumena Neo Contrast Delivery System, Fixed Powerhead Table Mount (Accessory)
• 10746190004943: Illumena Neo Contrast Delivery System, Powerpack Rackmount (Accessory)
• 10746190004936: Illumena Neo Contrast Delivery System, Console Wall Mount (Accessory)
• 10746190004929: Illumena Neo Contrast Delivery System, Electronic Pack Wall Mount (Accessory)
• 10746190004912: Illumena Neo Contrast Delivery System, Rackmount Powerpack Panel (Accessory)
• 10746190004882: Angiomat Illumena Syringe Heater (Accessory)
• 10746190004875: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004868: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004851: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004844: Angiomat Illumena Hand Button Start Switch (Accessory)
• 10746190004837: Angiomat Illumena Foot Switch, Remote Start (Accessory)
• 10746190004813: OptiBolus, Bolus Shaping Software, International (Accessory)
• 10746190004806: OptiBolus, Bolus Shaping Software, Domestic (Accessory)
• 10746190004752: Hand Button Start Switch (Accessory)
• 10746190004745: Hand Button Start Switch (Accessory)
• 10746190004714: Heater Blanket (Accessory)
• 10746190004363: OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface
• 10746190004356: OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface
• 10746190004349: OptiVantage Dual-Head CT Contrast Delivery System, Simultaneous Injection, OEM Interface
• 10746190004332: OptiVantage Dual-Head CT Contrast Delivery System, Simultaneous Injection, OEM Interface
• 10746190004110: OptiStar LE MR Contrast Delivery System, Demo Loan
• 10746190004080: Angiomat Illumena Contrast Delivery System, Demo Loan
• 10746190004073: Angiomat Illumena Contrast Delivery System, Refurbished
• 10746190004066: Angiomat Illumena Contrast Delivery System, Demo Loan
• 10746190004059: Angiomat Illumena Contrast Delivery System, Refurbished
• 10746190004042: Angiomat Illumena Contrast Delivery System, Refurbished
• 10746190004035: OptiVantage Dual-Head CT Contrast Delivery System, Demo Loan
• 10746190004028: OptiVantage Dual-Head CT Contrast Delivery System, Refurbished