Dornier Thulio Performance Fiber K2016360

GUDID 10816959021877

INNOVAQUARTZ LLC

General/multiple surgical laser system beam guide, reusable
Primary Device ID10816959021877
NIH Device Record Key11647baf-f0e3-43e1-826f-fd68dfb54aed
Commercial Distribution StatusIn Commercial Distribution
Brand NameDornier Thulio Performance Fiber
Version Model Number200um Single-Use Fiber
Catalog NumberK2016360
Company DUNS079295103
Company NameINNOVAQUARTZ LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816959021870 [Primary]
GS110816959021877 [Package]
Contains: 00816959021870
Package: Carton [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

On-Brand Devices [Dornier Thulio Performance Fiber]

10816959021884200um Reusable Fiber
10816959021877200um Single-Use Fiber

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