Bagley™ Self-Dilating Autoclavable Semi-Rigid Ureteroscope

GUDID 00821925007826

Gyrus Acmi, Inc.

Flexible fibreoptic ureteroscope

• Primary Device ID: 00821925007826
• NIH Device Record Key: 6f5c82a1-4775-4b57-b930-6ce805fb5d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bagley™ Self-Dilating Autoclavable Semi-Rigid Ureteroscope
• Version Model Number: REXMR-6A
• 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	00821925007826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052044

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

Sterilization

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

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

Moist Heat or Steam Sterilization

[00821925007826]

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: 2016-10-06

On-Brand Devices [Bagley™ Self-Dilating Autoclavable Semi-Rigid Ureteroscope]

• 00821925007826: REXMR-6A
• 00821925006232: MR-6LA URETEROSCOPE, 43cm
• 00821925006225: MR-6A URETEROSCOPE, 33cm