Kronner Manipujector

GUDID 20888937014765

Uterine manipulator, box of 12

Coopersurgical, Inc.

Uterine manipulator, single-use

• Primary Device ID: 20888937014765
• NIH Device Record Key: 894bd4ac-5171-4b7c-9813-bab6e4504e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kronner Manipujector
• Version Model Number: 6003
• 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	00888937015805 [Primary]
GS1	20888937014765 [Package]; Contains: 00888937015805; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904473

FDA Product Code

• HES: Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-04
• Device Publish Date: 2019-01-31

On-Brand Devices [Kronner Manipujector]

• 20888937014765: Uterine manipulator, box of 12
• 00888937015805: Uterine manipulator, box of 12