ZUMI

GUDID 20888937013225

ZUMI 4.5™ Uterine Manipulator-Injector O.D.: 4.5 mm • Length: 33 cm (13")

Coopersurgical, Inc.

Uterine manipulator, single-use

• Primary Device ID: 20888937013225
• NIH Device Record Key: b4d9994c-43a4-45a3-a6b4-6a8e00f55ecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZUMI
• Version Model Number: ZSI1151
• 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	00888937013221 [Primary]
GS1	20888937013225 [Package]; Contains: 00888937013221; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941458

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: 2016-09-14

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• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
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• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right