Uvision Hysteroscope 20010

GUDID 00853227708019

UVISION 360, INC.

Endoscope sheath, single-use

• Primary Device ID: 00853227708019
• NIH Device Record Key: f21ab7a4-c71a-4142-94d5-078d6b86b3d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uvision Hysteroscope
• Version Model Number: LUMDTx-A1
• Catalog Number: 20010
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853227708019 [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

[00853227708019]

High-level Disinfectant

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 [Uvision Hysteroscope]

• 00853227708019: LUMDTx-A1
• 00853277008015: LUMDTx-A1