SlimLine

GUDID 00821925010987

SlimLine Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope

Gyrus Acmi, Inc.

Rigid optical ureteroscope

• Primary Device ID: 00821925010987
• NIH Device Record Key: 68d22288-b5c9-455c-acb2-48acfaedcfc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SlimLine
• Version Model Number: REXMRO-715A
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 30 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925010987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012758

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [SlimLine]

• 00821925010987: SlimLine Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope
• 00821925009301: SlimLine self-Dilating Autoclavable Operating Semi-Rigid Ureteroscope
• 00821925002562: Semi-Rigid Scissors 5 Fr, (1.67mm), 42 CM
• 00821925002494: Semi-Rigid Biopsy Forceps 5 Fr (1,67 mm), 42 CM
• 00821925002470: Semi-Rigid Alligator Grasping Forceps 5 Fr, (1.67mm), 42 CM