Advincula Delineator Uterine Manipulator

GUDID 20888937021350

Advincula Delineator Uterine Manipulator with 3.0cm Soft Koh-Efficient

Coopersurgical, Inc.

Uterine manipulator, single-use

• Primary Device ID: 20888937021350
• NIH Device Record Key: 6222ccdf-4931-4618-a183-47bbd7bf23ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advincula Delineator Uterine Manipulator
• Version Model Number: AD750SC-KE30
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter
• Outer Diameter: 3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937021356 [Primary]
GS1	20888937021350 [Package]; Contains: 00888937021356; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180429

FDA Product Code

• HEW: Culdoscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-08-13

On-Brand Devices [Advincula Delineator Uterine Manipulator]

• 20888937021374: Advincula Delineator Uterine Manipulator with 4.0cm Soft Koh-Efficient
• 20888937021367: Advincula Delineator Uterine Manipulator with 3.5cm Soft Koh-Efficient
• 20888937021350: Advincula Delineator Uterine Manipulator with 3.0cm Soft Koh-Efficient
• 20888937021343: Advincula Delineator Uterine Manipulator with 2.5cm Soft Koh-Efficient