LUMINELLE DTx 360 Rotatable Disposable Sheaths 20020

GUDID 00853227708002

UVISION 360, INC.

Endoscope sheath, single-use

• Primary Device ID: 00853227708002
• NIH Device Record Key: 811a70f7-2252-4b0f-b46e-8cc2c3b81a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMINELLE DTx 360 Rotatable Disposable Sheaths
• Version Model Number: LUMDTx-360
• Catalog Number: 20020
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853227708002 [Primary]
GS1	10853227708009 [Package]; Package: Pouch [1 Units]; In Commercial Distribution

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: true

[00853227708002]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-05-30

On-Brand Devices [LUMINELLE DTx 360 Rotatable Disposable Sheaths]

• 00853227708002: LUMDTx-360
• 00853277008008: LUMDTx-360