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.
Vascular implant detacher, single-use, sterile| 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.
| 06958698025260 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025277 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025284 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025291 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025307 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025314 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025321 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
| 06958698025338 - Numen | 2024-11-14 The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) fo |
Trademark Results [NumenFR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUMENFR 79315347 not registered Live/Pending |
MicroPort NeuroTech (Shanghai) Co.,Ltd. 2021-03-31 |
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