Aptra

GUDID 10850023925388

Aptra Single-Use Digital Flexible Cystoscope

Otu Medical Inc.

Flexible video cystoscope, single-use

• Primary Device ID: 10850023925388
• NIH Device Record Key: 1b057fdf-ab0b-4d8b-bad7-03752729e1e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptra
• Version Model Number: BDCYSD01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850023925381 [Primary]
GS1	10850023925388 [Package]; Contains: 00850023925381; Package: [2 Units]; In Commercial Distribution
GS1	20850023925385 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212202

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-08
• Device Publish Date: 2024-09-30

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