Dornier MedTech HOL400R

GUDID 00810116020409

Dornier SmartFlex 400 Reusable Laser Fiber - Dornier Direct

DORNIER MEDTECH AMERICA, INC.

Laser lithotripsy system

• Primary Device ID: 00810116020409
• NIH Device Record Key: eb98dcee-b604-4614-84b9-a92208f4213e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier MedTech
• Version Model Number: 400 Micron Reusable
• Catalog Number: HOL400R
• Company DUNS: 130789944
• Company Name: DORNIER MEDTECH AMERICA, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00810116020409 [Package]; Contains: 00810116020454; Package: box [3 Units]; In Commercial Distribution
GS1	00810116020454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123385

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-10

On-Brand Devices [Dornier MedTech]

• 00810116020713: Digital Video Processor, Input Voltage: 5V 2A (for use with Dornier Ureteroscope)
• 00810116020690: Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insertion Ch
• 00810116020683: Hydrophilic Nitinol Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.
• 00810116020652: Helical Basket, 2.5 Fr diameter, 120 cm length.
• 00810116020645: Tipless Basket, 1.8 Fr diameter, 120 cm length.
• 00810116020638: Tipless Basket, 1.5 Fr diameter, 120 cm length.
• 00810116020621: Combi Nitinol Guidewire, 0.038" diameter, 150 cm length, 3 cm tip.
• 00810116020553: PTFE Coated Stainless Steel Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.
• 00810116020430: Dornier SmartFlex 200 Reusable Laser Fiber - Dornier Direct
• 00810116020423: Dornier SmartFlex 1000 Reusable Laser Fiber - Dornier Direct
• 00810116020461: Dornier SmartFlex 600 Reusable Laser Fiber - Dornier Direct
• 00810116020409: Dornier SmartFlex 400 Reusable Laser Fiber - Dornier Direct
• 00810116020393: Dornier SmartFlex 270 Reusable Laser Fiber - Dornier Direct
• 00810116020300: Dornier SingleFlex 1000 Laser Fiber - Dornier Direct
• 00810116020294: Dornier SingleFlex 600 Laser Fiber - Dornier Direct
• 00810116020287: Dornier SingleFlex 400 Laser Fiber - Dornier Direct
• 00810116020270: Dornier SingleFlex 270 Laser Fiber - Dornier Direct
• 00810116020317: Dornier SingleFlex 200 Laser Fiber - Dornier Direct
• 00810116020324: Dornier GentleFlex 200 Laser Fiber - Dornier Direct
• 00810116020263: RFID Single Use 200 Series Flex (270 Micron) Ball Tip Laser Fiber
• 00810116020232: RFID Reusable 200 Series (270 Micron) Laser Fiber
• 00810116020225: RFID Single Use 200 Series (270 Micron) Laser Fiber
• 00810116020089: RFID Reusable 270 Micron Laser Fiber
• 00810116020096: RFID Reusable 400 Micron Laser Fiber
• 00810116020102: RFID Reusable 600 Micron Laser Fiber
• 00810116020119: RFID Reusable 1000 Micron Laser Fiber
• 00810116020126: RFID Single Use 1000 Micron Laser Fiber
• 00810116020027: RFID Single Use 600 Micron Laser Fiber
• 00810116020140: RFID Single Use 400 Micron Laser Fiber
• 00810116020157: RFID Single Use 270 Micron Laser Fiber
• 00810116022595: 600 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters
• 00810116022564: 400 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters
• 00810116022557: 600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 2.5 meters
• 00810116022533: 400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 2.5 meters
• 00810116022441: 600 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
• 00810116022434: 400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
• 00810116022410: 365 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
• 00810116022397: 600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
• 00810116021123: Dornier SmartFlex 1000 High Energy Laser Fiber - Dornier Direct
• 00810116021116: Dornier SmartFlex 600 High Energy Laser Fiber - Dornier Direct
• 00810116021109: Dornier SmartFlex 400 High Energy Laser Fiber - Dornier Direct
• 00810116021093: Dornier SmartFlex 270 High Energy Laser Fiber - Dornier Direct
• 00810116021086: Dornier SmartFlex 200 High Energy Laser Fiber - Dornier Direct
• 00810116020836: Dornier SingleFlex 1000 High Energy Laser Fiber - Dornier Direct
• 00810116020829: Dornier SingleFlex 600 High Energy Laser Fiber - Dornier Direct
• 00810116020812: Dornier SingleFlex 400 High Energy Laser Fiber - Dornier Direct
• 00810116020744: Dornier SingleFlex 270 High Energy Laser Fiber - Dornier Direct
• 00810116020737: Dornier SingleFlex 200 High Energy Laser Fiber - Dornier Direct
• 00810116020720: Dornier 200 GentleFlex High Energy Laser Fiber - Dornier Direct
• 00810116022915: Nitonol Stone Extractor, 2.0Fr x 120cm, 8mm Open Tip