SemiFlex Scope

GUDID B324MFENDO600

60 centimeter single use endoscope for urological application.

MAXIFLEX, LLC

Flexible fibreoptic ureteroscope

• Primary Device ID: B324MFENDO600
• NIH Device Record Key: d9bb3b33-4d87-4035-ab43-413051ec4c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SemiFlex Scope
• Version Model Number: MF-ENDO 60
• Company DUNS: 198887072
• Company Name: MAXIFLEX, 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

• Length: 60 Centimeter
• Catheter Gauge: 9.5 French
• Length: 60 Centimeter
• Catheter Gauge: 9.5 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B324MFENDO600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111480

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

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

[B324MFENDO600]

Hydrogen Peroxide

[B324MFENDO600]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SemiFlex Scope]

• B324MFENDO65LUEA20: MF-ENDO 65 LU E A2
• B324MFENDO65LUEA10: 65 centimeter limited use endoscope for urological application.
• B324MFENDO65LUE0: 65 centimeter limited use endoscope for urological application.
• B324MFENDO65LUA10: 65 centimeter limited use endoscope for urological application.
• B324MFENDO65LU0: 65 centimeter limited use endoscope for urological application.
• B324MFENDO65EA10: 65 centimeter single use endoscope for urological application.
• B324MFENDO65E0: 65 centimeter single use endoscope for urological application.
• B324MFENDO65A10: 65 centimeter single use endoscope for urological application.
• B324MFENDO650: 65 centimeter single use endoscope for urological application.
• B324MFENDO60LUEA10: 60 centimeter limited use endoscope for urological application.
• B324MFENDO60LUE0: 60 centimeter limited use endoscope for urological application.
• B324MFENDO60LUA10: 60 centimeter limited use endoscope for urological application.
• B324MFENDO60LU0: 60 centimeter limited use endoscope for urological application.
• B324MFENDO60EA10: 60 centimeter single use endoscope for urological application.
• B324MFENDO60E0: 60 centimeter single use endoscope for urological application.
• B324MFENDO60A10: 60 centimeter single use endoscope for urological application.
• B324MFENDO600: 60 centimeter single use endoscope for urological application.
• B324MFENDO55LUEA10: 55 centimeter limited use endoscope for urological application.
• B324MFENDO55LUE0: 55 centimeter limited use endoscope for urological application.
• B324MFENDO55LUA10: 55 centimeter limited use endoscope for urological application.
• B324MFENDO55LU0: 55 centimeter limited use endoscope for urological application.
• B324MFENDO55EA10: 55 centimeter single use endoscope for urological application.
• B324MFENDO55E0: 55 centimeter single use endoscope for urological application.
• B324MFENDO55A10: 55 centimeter single use endoscope for urological application.
• B324MFENDO550: 55 centimeter single use endoscope for urological application.
• B324MFENDO45LUEA10: 45 centimeter limited use endoscope for urological application.
• B324MFENDO45LUE0: 45 centimeter limited use endoscope for urological application.
• B324MFENDO45LUA10: 45 centimeter limited use endoscope for urological application.
• B324MFENDO45LU0: 45 centimeter limited use endoscope for urological application.
• B324MFENDO45EA10: 45 centimeter single use endoscope for urological application.
• B324MFENDO45E0: 45 centimeter single use endoscope for urological application.
• B324MFENDO45A10: 45 centimeter single use endoscope for urological application.
• B324MFENDO450: 45 centimeter single use endoscope for urological application.