Cystosure

GUDID 00866403000234

Scope, 70 deg, 2.7 mm, long (270mm)

EMMY MEDICAL LLC

Rigid cystoscope

• Primary Device ID: 00866403000234
• NIH Device Record Key: 7a421952-7c38-4fa8-a9e8-8ff6ef302c0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cystosure
• Version Model Number: 10-300
• Company DUNS: 052321836
• Company Name: EMMY MEDICAL LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter
• Outer Diameter: 2.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866403000234 [Primary]

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00866403000234]

Ethylene Oxide;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-25
• Device Publish Date: 2019-04-17

On-Brand Devices [Cystosure]

• 00866403000265: Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long
• 00866403000234: Scope, 70 deg, 2.7 mm, long (270mm)
• 00866403000210: 16Fr Cystosure Plus, 16Fr, silicone catheter
• 00866403000203: Cystosure XL, 16 Fr, silicone catheter