Tube Set 0600-2203-000

GUDID 10817984011055

Sinus Vacu-Irrigator

MECTRA LABS, INC.

Surgical irrigation/aspiration system Surgical irrigation/aspiration system
Primary Device ID10817984011055
NIH Device Record Key1d557e5e-dc81-4cc8-a5e2-c2e0e2a50577
Commercial Distribution Discontinuation2020-01-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTube Set
Version Model Number0600-2203-000
Catalog Number0600-2203-000
Company DUNS606939072
Company NameMECTRA LABS, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-3968
Emailmectrasales@mectralabs.com
Phone+1(800)323-3968
Emailmectrasales@mectralabs.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
Handling Environment TemperatureBetween 20 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817984011058 [Primary]
GS110817984011055 [Package]
Contains: 00817984011058
Package: Inner pack [10 Units]
Discontinued: 2020-01-10
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GBXCATHETER, IRRIGATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-13
Device Publish Date2019-01-29

On-Brand Devices [Tube Set]

10817984011086High Flow Irrigation
10817984011055Sinus Vacu-Irrigator
10817984011024Double Bottle
10817984011017Lap Vac-Irrigator
10817984011000Dual Spike
10817984010997Pump & Vacuum
10817984010348Tube Set Bifurcated Single Spike
10817984010355Tube Set Bifurcated Dual Spike

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