Mr. Clear Purple 0600-AF001-000

GUDID 10817984010195

Mr. Clear Purple Dobber Top

MECTRA LABS, INC.

Rigid optical laparoscope

• Primary Device ID: 10817984010195
• NIH Device Record Key: ac91d473-fa88-4359-bcfc-46e631f2696c
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mr. Clear Purple
• Version Model Number: 0600-AF001-000
• Catalog Number: 0600-AF001-000
• 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	00817984010198 [Primary]
GS1	10817984010195 [Package]; Contains: 00817984010198; Package: Inner Pack [20 Units]; Discontinued: 2020-01-10; Not in Commercial Distribution
GS1	20817984010192 [Package]; Contains: 00817984010198; Package: Case [25 Units]; Discontinued: 2020-01-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993604

FDA Product Code

• OCT: Anti fog solution and accessories, endoscopy

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: 2019-01-24

On-Brand Devices [Mr. Clear Purple]

• 10817984011130: Mr. Clear Purple Foam Pad
• 10817984011123: Mr. Clear Purple Foam Pad
• 20817984010949: Mr. Clear Purple No Foam Pad
• 10817984010935: Mr. Clear Purple Needle Counter Box
• 10817984010201: Mr. Clear Purple Foam Pad
• 10817984010195: Mr. Clear Purple Dobber Top
• 20817984010185: Mr. Clear Purple Wipe
• 10817984010133: Dry To The Touch