Century Uterine Manipulator

GUDID GYNX101601

GYNEX CORPORATION

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

• Primary Device ID: GYNX101601
• NIH Device Record Key: db02edbd-75b3-4b5f-9180-80f6b4f26d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Century Uterine Manipulator
• Version Model Number: 10-160
• Company DUNS: 012997685
• Company Name: GYNEX CORPORATION
• Device Count: 12
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	GYNX101600 [Unit of Use]
HIBCC	GYNX101601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022503

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: 2016-10-10

Devices Manufactured by GYNEX CORPORATION

• GYNX16000 - Gynex: 2024-01-03
• GYNX291000 - Gynex: 2024-01-03
• GYNX292000 - Gynex: 2024-01-03
• GYNX293500 - Gynex: 2024-01-03
• GYNX295500 - Gynex: 2024-01-03
• GYNX297000 - Gynex: 2024-01-03
• GYNX298000 - Gynex: 2024-01-03
• GYNX298500 - Gynex: 2024-01-03