Bagley™ Self-Dilating Autoclavable Semi-Rigid Ureteroscope

GUDID 00821925007826

Gyrus Acmi, Inc.

Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope Flexible fibreoptic ureteroscope 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

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