Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®

GUDID 20888937012747

Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®

Coopersurgical, Inc.

Uterine manipulator, single-use

• Primary Device ID: 20888937012747
• NIH Device Record Key: e970f913-56e6-48b0-bf1f-9a277f881e5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®
• Version Model Number: AD750-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 Identifiers

Device Issuing Agency	Device ID
GS1	00888937012743 [Primary]
GS1	20888937012747 [Package]; Contains: 00888937012743; 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: 2016-09-23

Devices Manufactured by Coopersurgical, Inc.

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• 00888937028355 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast with phenol red. 10 ml
• 00888937028386 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 10 ml
• 00888937028393 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 60 ml
• 00888937028409 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 10 ml
• 00888937028416 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 60 ml
• 00888937028430 - ORIGIO Sequential Fert: 2026-02-13 ORIGIO Sequential Fert