Aptra

GUDID 00850023925015

Image System

Otu Medical Inc.

Endoscopic video image processing unit

• Primary Device ID: 00850023925015
• NIH Device Record Key: 99e3ddbf-6898-49e7-9213-3e4380b91399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptra
• Version Model Number: BDVP01
• Company DUNS: 100796993
• Company Name: Otu Medical 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	00850023925015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181977

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: 2021-12-07
• Device Publish Date: 2021-11-29

On-Brand Devices [Aptra]

• 10850023925029: Single-Use Digital Flexible Ureteroscope
• 10850023925036: Single-Use Digital Flexible Ureteroscope
• 00850023925015: Image System
• 10850023925395: Aptra Single-Use Digital Flexible Cystoscope
• 10850023925388: Aptra Single-Use Digital Flexible Cystoscope