Uvision Hysteroscope Cable

GUDID 00853227708026

UVISION 360, INC.

Flexible video cystoscope, reusable

• Primary Device ID: 00853227708026
• NIH Device Record Key: bc7b7057-fa92-4e46-ad8d-47b57a6b0557
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uvision Hysteroscope Cable
• Version Model Number: 20050
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853227708026 [Primary]
GS1	10853227708023 [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: false
• Device Is Sterile: false

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 Cable]

• 00853227708026: 20050
• 00853277008022: 20050