Unicare Manipulator

GUDID B248100041

CLEARPATH SURGICAL, INC.

Uterine manipulator, single-use Uterine manipulator, single-use

• Primary Device ID: B248100041
• NIH Device Record Key: b1c2ed17-cc1a-421f-94eb-6d46ba537034
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unicare Manipulator
• Version Model Number: 100041
• Company DUNS: 080149780
• Company Name: CLEARPATH SURGICAL, 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B248100041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163214

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: 2017-11-19

Devices Manufactured by CLEARPATH SURGICAL, INC.

• B248100040 - Unicare System: 2018-12-07
• B248100041 - Unicare Manipulator: 2018-12-07
• B248100041 - Unicare Manipulator: 2018-12-07