Ethicon EPT03 0600-2159-000

GUDID 10817984010041

Pressurized Bag Irrigation Tube Set With Spike

MECTRA LABS, INC.

Surgical irrigation/aspiration system

• Primary Device ID: 10817984010041
• NIH Device Record Key: 68480b2e-f1c8-4121-a376-52e6a7eff858
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ethicon EPT03
• Version Model Number: 0600-2159-000
• Catalog Number: 0600-2159-000
• 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	00817984010044 [Primary]
GS1	10817984010041 [Package]; Contains: 00817984010044; Package: Inner pack [6 Units]; Discontinued: 2020-01-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895756

FDA Product Code

• GBX: CATHETER, IRRIGATION

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: 2019-01-29

Devices Manufactured by MECTRA LABS, INC.

• 10817984010300 - Bahama Blade: 2020-02-06 Bahama Blade
• 10817984010966 - Bahama Hook: 2020-02-06 Bahama Hook
• 10817984011161 - Bahama Hook: 2020-02-06 Bahama Hook Metal
• 10817984010355 - Tube Set: 2020-01-13 Tube Set Bifurcated Dual Spike
• 10817984010362 - Laser Lavage: 2020-01-13 Laser Lavage 32CM Single Spike
• 10817984010003 - Master Lavage: 2020-01-13 Master Lavage Single Spike
• 10817984010010 - Master Lavage: 2020-01-13 Master Lavage Dual Spike
• 10817984010027 - Master Lavage: 2020-01-13 Master Lavage Double Bottle