Electro Lavage 0600-3141-000

GUDID 10817984010577

Electro Lavage Needle Single Spike

MECTRA LABS, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 10817984010577
• NIH Device Record Key: 74c1e985-bc89-46ac-afe8-eee48667d0a4
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Electro Lavage
• Version Model Number: 0600-3141-000
• Catalog Number: 0600-3141-000
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817984010570 [Primary]
GS1	10817984010577 [Package]; Contains: 00817984010570; 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]

• 10817984010607: Electro Lavage Blunt
• 10817984010591: Electro Lavage Needle Double Bottle
• 10817984010584: Electro Lavage Needle Dual Spike
• 10817984010577: Electro Lavage Needle Single Spike
• 10817984010560: Electro Lavage Needle
• 10817984010553: Electro Lavage
• 10817984010546: Electro Lavage Loop Dual Spike
• 10817984010539: Electro Lavage Loop Single Spike
• 10817984010522: Electro Lavage Loop
• 10817984010515: Electro Lavage J Hook Double Bottle
• 10817984010508: Electro Lavage J Hook Dual Spike
• 10817984010492: Electro Lavage J Hook Single Spike
• 10817984010485: Electro Lavage J Hook
• 10817984010478: Electro Lavage L Hook Double Bottle
• 10817984010461: Electro Lavage L Hook Dual Spike
• 10817984010454: Electro Lavage L Hook Single Spike
• 10817984010447: Electro Lavage L Hook
• 10817984010430: Electro Lavage Spatula Double Bottle
• 10817984010423: Electro Lavage Spatula Dual Spike
• 10817984010416: Electro Lavage Spatula Single Spike
• 10817984010409: Electro Lavage Spatula