NumenFR

GUDID 06958698011690

The MicroPort NeuroTech NumenFR Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen Coil Embolization System. The device is operated by two pre-loaded batteries.

MicroPort NeuroTech (Shanghai) Co., Ltd.

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• Primary Device ID: 06958698011690
• NIH Device Record Key: 7043dae5-2760-4475-9fd3-f193582fcd45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NumenFR
• Version Model Number: E101
• Company DUNS: 551973856
• Company Name: MicroPort NeuroTech (Shanghai) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06958698011690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203625

FDA Product Code

• HCG: Device, Neurovascular Embolization

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: 2022-03-23
• Device Publish Date: 2022-03-15

Devices Manufactured by MicroPort NeuroTech (Shanghai) Co., Ltd.

• 06958698009918 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009925 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009932 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009949 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009956 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009963 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009970 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo
• 06958698009987 - Numen: 2022-03-23 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo