ALLY II UPS

GUDID 00888937027587

ALLY II UPS (Uterine Positioning System)

Coopersurgical, Inc.

Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable Uterine manipulator, reusable

• Primary Device ID: 00888937027587
• NIH Device Record Key: c4f663a0-06d6-4d9d-848b-94d8e46500d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLY II UPS
• Version Model Number: LAU-UPS2
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937027587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223064

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

Devices Manufactured by Coopersurgical, Inc.

• 60888937027176 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027183 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027190 - ERPeak: 2024-04-18 IVD Sample kit
• 60888937027206 - ERPeak: 2024-04-18 IVD Sample kit
• 00888937026870 - Mara Console: 2024-03-21 Mara Console- Endometrial Ablation
• 00888937023817 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023824 - K-Systems: 2024-02-27 L126 IVF, Standard Heat Right
• 00888937023831 - K-Systems: 2024-02-27 L126 IVF, RI Witness Right