LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath 20060

GUDID 10853227708054

UVISION 360, INC.

Endoscope sheath, single-use

• Primary Device ID: 10853227708054
• NIH Device Record Key: c41b9a24-bdf3-4d20-9979-58bfe61945d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath
• Version Model Number: LUMDTx-360R
• Catalog Number: 20060
• 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: 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	00853227708057 [Primary]
GS1	10853227708054 [Package]; Contains: 00853227708057; Package: Pouch [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190827

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

[10853227708054]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-25
• Device Publish Date: 2019-06-17

On-Brand Devices [LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath]

• 10853227708054: LUMDTx-360R
• 10853277008050: LUMDTx-360R