Luminelle DTx Control Hub

GUDID 00853277008039

UVISION 360, INC.

Flexible video cystoscope, reusable

• Primary Device ID: 00853277008039
• NIH Device Record Key: 421f6ce6-30f6-461e-84e7-2ca14c3f0b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminelle DTx Control Hub
• Version Model Number: 20012
• Company DUNS: 080826327
• Company Name: UVISION 360, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853277008039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181909

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-05
• Device Publish Date: 2019-05-30

On-Brand Devices [Luminelle DTx Control Hub]

• 00853227708033: 20012
• 00853277008039: 20012