SlimLine™ Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscop

GUDID 00821925006676

MRO-742A SLIMLINE URETEROSCOPE

Gyrus Acmi, Inc.

Rigid ureteroscope

• Primary Device ID: 00821925006676
• NIH Device Record Key: deb006ff-751c-454d-9f09-ca365a1e6603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SlimLine™ Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscop
• Version Model Number: MRO-742A
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925006676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011849

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

[00821925006676]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-18

On-Brand Devices [SlimLine™ Self-Dilating Autoclavable Operating Semi-Rigid Ureteroscop]

• 00821925010970: MRO-715A SlimLine Ureteroscope,15cm
• 00821925009295: MRO-733A SLIMLINE URETEROSCOPE,SHORT
• 00821925007840: REPMRO-742A
• 00821925006676: MRO-742A SLIMLINE URETEROSCOPE