Master Lavage 0600-3002-000

GUDID 10817984010010

Master Lavage Dual Spike

MECTRA LABS, INC.

Surgical irrigation/aspiration handpiece, single-use
Primary Device ID10817984010010
NIH Device Record Keybcc8959a-c354-458f-89fe-bc989723946e
Commercial Distribution Discontinuation2020-01-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMaster Lavage
Version Model Number0600-3002-000
Catalog Number0600-3002-000
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
GS100817984010013 [Primary]
GS110817984010010 [Package]
Contains: 00817984010013
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 Number4
Public Version Date2020-01-13
Device Publish Date2019-01-25

On-Brand Devices [Master Lavage]

10817984010393Master Lavage Filter
10817984010386Master Lavage 36CM Double Bottle
10817984010379Master Lavage 36CM Dual Spike
10817984010027Master Lavage Double Bottle
10817984010010Master Lavage Dual Spike
10817984010003Master Lavage Single Spike

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