Robotic FloShield/Plus FSR-05-8530AU

GUDID 00815128020713

The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site. This is a convenience kit containing one Robotic FloShield/Plus sheath assembly and one Robotic FloShield/Plus tube set assembly.

MINIMALLY INVASIVE DEVICES, INC.

Endoscope lens cleaner, gas/fluid, single-use

• Primary Device ID: 00815128020713
• NIH Device Record Key: b11cafcc-1e84-4460-88e1-8aa4f2c9f6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Robotic FloShield/Plus
• Version Model Number: FSR-05-8530AU
• Catalog Number: FSR-05-8530AU
• Company DUNS: 793517660
• Company Name: MINIMALLY INVASIVE DEVICES, 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: true
• 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: 1-614-340-3349
• Email: inquiries@floshield.com
• Phone: 1-614-340-3349
• Email: inquiries@floshield.com

Device Dimensions

• Lumen/Inner Diameter: 8.5 Millimeter
• Lumen/Inner Diameter: 8.5 Millimeter
• Lumen/Inner Diameter: 8.5 Millimeter
• Lumen/Inner Diameter: 8.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815128020713 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-07-29

On-Brand Devices [Robotic FloShield/Plus]

• 00815128020713: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device int
• 00815128020706: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device int
• 00815128020690: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device int
• 00815128020645: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device int
• 00815128020638: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device int
• 00815128020621: The 8.5mm Robotic FloShield System is a single-use, disposable laparoscopic accessory device int
• 00815128020614: FloShield/Plus Robotic Tube Set is an accessory for 8.5mm FloShield Robotic Sheath Assembly but