ClearView

GUDID 00814247020130

Sound/Dilator (accessory for ClearView Uterine Manipulator)

CLINICAL INNOVATIONS, LLC

Uterine manipulator, single-use

• Primary Device ID: 00814247020130
• NIH Device Record Key: d2a9594f-82ef-4bf8-a01a-c1862c391ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearView
• Version Model Number: DSD-1000
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020130 [Primary]
GS1	10814247020137 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940681

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-09-01

On-Brand Devices [ClearView]

• 10814247020144: ClearView accessory - Disposable Sound Dilator
• 00814247020130: Sound/Dilator (accessory for ClearView Uterine Manipulator)