LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) 20070

GUDID 00853277008060

The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).

UVISION 360, INC.

Endoscope sheath, single-use

• Primary Device ID: 00853277008060
• NIH Device Record Key: 0dc9e3e0-441f-4175-9dfa-a41f89cccfc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic)
• Version Model Number: LUMDx-360
• Catalog Number: 20070
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853277008060 [Primary]
GS1	10853277008067 [Package]; Package: Pouch [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192278

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

[00853277008060]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

Devices Manufactured by UVISION 360, INC.

• 10853277008104 - LUMINELLE Aspirator: 2024-03-08 LUMINELLE Aspirator
• 10853277008081 - LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy): 2021-08-23 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
• 10853277008098 - LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy): 2021-08-23 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
• 00853277008060 - LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic): 2019-11-15The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).
• 00853277008060 - LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic): 2019-11-15 The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).
• 00853277008008 - LUMINELLE DTx 360 Rotatable Disposable Sheaths: 2019-11-05
• 00853277008015 - Uvision Hysteroscope: 2019-11-05
• 00853277008022 - Uvision Hysteroscope Cable: 2019-11-05
• 00853277008039 - Luminelle DTx Control Hub: 2019-11-05