LUMINELLE DTx Hysteroscopy System 20030

GUDID 00853277008046

Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

UVISION 360, INC.

Flexible video cystoscope, reusable

• Primary Device ID: 00853277008046
• NIH Device Record Key: 65af102d-0a51-4137-9e91-f854a917cffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMINELLE DTx Hysteroscopy System
• Version Model Number: LumDTX-A
• Catalog Number: 20030
• 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: true
• 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

Customer Support Contacts

• Phone: 615.943.8368
• Email: Allison.LondonBrown@UVision360.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853277008046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181909

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00853277008046]

High-level Disinfectant;Ethylene Oxide

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 Hysteroscopy System]

• 00853227708040: Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of t
• 00853277008046: Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of t