ALLY II UPS (Uterine Positioning System)

GUDID 00888937026740

ALLY II UPS (Uterine Positioning System)

Coopersurgical, Inc.

Uterine manipulator, single-use

• Primary Device ID: 00888937026740
• NIH Device Record Key: a7c9e2e0-edd2-41ad-8e8e-c8250b3a2b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLY II UPS (Uterine Positioning System)
• Version Model Number: AU-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	00888937026740 [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: 2022-12-14
• Device Publish Date: 2022-12-06

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