Dornier MedTech FTSXCVRLG

GUDID 10810116023025

Nonsterile Equipment Large Cover for the Movement Footswitch 26” x 26”

DORNIER MEDTECH AMERICA, INC.

Medical equipment drape, single-use
Primary Device ID10810116023025
NIH Device Record Keyb0f9084a-82c9-455c-995a-c7213c54812e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDornier MedTech
Version Model NumberEquipment Cover (Movement Footswitch)
Catalog NumberFTSXCVRLG
Company DUNS130789944
Company NameDORNIER MEDTECH AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810116023028 [Primary]
GS110810116023025 [Package]
Contains: 00810116023028
Package: Box [100 Units]
In Commercial Distribution

FDA Product Code

IZISystem, X-Ray, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

On-Brand Devices [Dornier MedTech]

00810116020713Digital Video Processor, Input Voltage: 5V 2A (for use with Dornier Ureteroscope)
00810116020690Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insertion Channel Width: 1.2 mm, Bending Angle: -275° - +275°, Working Length: 650 mm
00810116020683Hydrophilic Nitinol Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.
00810116020652Helical Basket, 2.5 Fr diameter, 120 cm length.
00810116020645Tipless Basket, 1.8 Fr diameter, 120 cm length.
00810116020638Tipless Basket, 1.5 Fr diameter, 120 cm length.
00810116020621Combi Nitinol Guidewire, 0.038" diameter, 150 cm length, 3 cm tip.
00810116020553PTFE Coated Stainless Steel Guidewire, 0.035" diameter, 150 cm length, 3 cm tip.
00810116020430Dornier SmartFlex 200 Reusable Laser Fiber - Dornier Direct
00810116020423Dornier SmartFlex 1000 Reusable Laser Fiber - Dornier Direct
00810116020461Dornier SmartFlex 600 Reusable Laser Fiber - Dornier Direct
00810116020409Dornier SmartFlex 400 Reusable Laser Fiber - Dornier Direct
00810116020393Dornier SmartFlex 270 Reusable Laser Fiber - Dornier Direct
00810116020300Dornier SingleFlex 1000 Laser Fiber - Dornier Direct
00810116020294Dornier SingleFlex 600 Laser Fiber - Dornier Direct
00810116020287Dornier SingleFlex 400 Laser Fiber - Dornier Direct
00810116020270Dornier SingleFlex 270 Laser Fiber - Dornier Direct
00810116020317Dornier SingleFlex 200 Laser Fiber - Dornier Direct
00810116020324Dornier GentleFlex 200 Laser Fiber - Dornier Direct
00810116020263RFID Single Use 200 Series Flex (270 Micron) Ball Tip Laser Fiber
00810116020232RFID Reusable 200 Series (270 Micron) Laser Fiber
00810116020225RFID Single Use 200 Series (270 Micron) Laser Fiber
00810116020089RFID Reusable 270 Micron Laser Fiber
00810116020096RFID Reusable 400 Micron Laser Fiber
00810116020102RFID Reusable 600 Micron Laser Fiber
00810116020119RFID Reusable 1000 Micron Laser Fiber
00810116020126RFID Single Use 1000 Micron Laser Fiber
00810116020027RFID Single Use 600 Micron Laser Fiber
00810116020140RFID Single Use 400 Micron Laser Fiber
00810116020157RFID Single Use 270 Micron Laser Fiber
00810116022595600 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters
00810116022564400 micron core/730 micron OD SMA Diode Laser Fiber, 3.5 meters
00810116022557600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 2.5 meters
00810116022533400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 2.5 meters
00810116022441600 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
00810116022434400 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
00810116022410365 micron core/730 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
00810116022397600 micron core/1040 micron OD Luer Lock Diode Laser Fiber, 3.5 meters
00810116021123Dornier SmartFlex 1000 High Energy Laser Fiber - Dornier Direct
00810116021116Dornier SmartFlex 600 High Energy Laser Fiber - Dornier Direct
00810116021109Dornier SmartFlex 400 High Energy Laser Fiber - Dornier Direct
00810116021093Dornier SmartFlex 270 High Energy Laser Fiber - Dornier Direct
00810116021086Dornier SmartFlex 200 High Energy Laser Fiber - Dornier Direct
00810116020836Dornier SingleFlex 1000 High Energy Laser Fiber - Dornier Direct
00810116020829Dornier SingleFlex 600 High Energy Laser Fiber - Dornier Direct
00810116020812Dornier SingleFlex 400 High Energy Laser Fiber - Dornier Direct
00810116020744Dornier SingleFlex 270 High Energy Laser Fiber - Dornier Direct
00810116020737Dornier SingleFlex 200 High Energy Laser Fiber - Dornier Direct
00810116020720Dornier 200 GentleFlex High Energy Laser Fiber - Dornier Direct
00810116022915Nitonol Stone Extractor, 2.0Fr x 120cm, 8mm Open Tip

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