Electro Lavage MG 0600-MG3131-000

GUDID 10817984010867

Electro Lavage MG Loop Single Spike

MECTRA LABS, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10817984010867
• NIH Device Record Key: aff78d5d-d6f8-4d5f-a3c1-c9b1f589c00d
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Electro Lavage MG
• Version Model Number: 0600-MG3131-000
• Catalog Number: 0600-MG3131-000
• Company DUNS: 606939072
• Company Name: MECTRA LABS, 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817984010860 [Primary]
GS1	10817984010867 [Package]; Contains: 00817984010860; Package: Inner pack [10 Units]; Discontinued: 2020-01-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955352

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-13
• Device Publish Date: 2019-01-25

On-Brand Devices [Electro Lavage MG]

• 10817984010881: Electro Lavage MG Loop Double Bottle
• 10817984010874: Electro Lavage MG Loop Dual Spike
• 10817984010867: Electro Lavage MG Loop Single Spike
• 10817984010850: Electro Lavage MG J Hook Double Bottle
• 10817984010843: Electro Lavage MG J Hook Dual Spike
• 10817984010836: Electro Lavage MG J Hook Single Spike
• 10817984010829: Electro Lavage MG L Hook Double Bottle
• 10817984010812: Electro Lavage MG L Hook Dual Spike
• 10817984010805: Electro Lavage MG L Hook Single Spike
• 10817984010799: Electro Lavage MG Spatula Double Bottle
• 10817984010782: Electro Lavage MG Spatula Dual Spike
• 10817984010775: Electro Lavage MG Spatula Single Spike
• 10817984010768: Master Lavage MG Filter