ClearView Uterine Manipulator

GUDID 20814247020011

ClearView Uterine Manipulator, 7cm

CLINICAL INNOVATIONS, LLC

Uterine manipulator, single-use

• Primary Device ID: 20814247020011
• NIH Device Record Key: f194c860-332b-4940-9284-413dc08210d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearView Uterine Manipulator
• Version Model Number: UM700
• 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	00814247020017 [Primary]
GS1	10814247020014 [Package]; Contains: 00814247020017; Package: [5 Units]; In Commercial Distribution
GS1	20814247020011 [Package]; Contains: 10814247020014; Package: [4 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 Uterine Manipulator]

• 20814247020608: ClearView Uterine Manipulator, 9cm
• 20814247020486: ClearView Uterine Manipulator, long tip
• 20814247020479: ClearView Uterine Manipulator, regular tip
• 20814247020011: ClearView Uterine Manipulator, 7cm