Advincula Delineator™ Uterine Manipulator with 2.5 cm Stainless Steel Koh-Effici

GUDID 20888937013812

Advincula Delineator™ Uterine Manipulator with 2.5 cm Stainless Steel Koh-Efficient®

Coopersurgical, Inc.

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• Primary Device ID: 20888937013812
• NIH Device Record Key: f005234c-4f0e-4a12-b51d-653294bf448f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advincula Delineator™ Uterine Manipulator with 2.5 cm Stainless Steel Koh-Effici
• Version Model Number: AD750-KES25
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00888937013818 [Primary]
GS1	20888937013812 [Package]; Contains: 00888937013818; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143650

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: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-10-24

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