FDA UDI
In Commercial Distribution
🇺🇸 United States
NumenFR
DI: 06958698011690
·
Model: E101
·
MicroPort NeuroTech (Shanghai) Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NumenFR
- Primary DI
- 06958698011690
- Version / Model
- E101
- Company Name
- MicroPort NeuroTech (Shanghai) Co., Ltd.
- Labeler DUNS
- 551973856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-15
- Public Version
- 3
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 7043dae5-2760-4475-9fd3-f193582fcd45
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HCG | Device, Neurovascular Embolization | Neurology | 882.5950 | 2 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60637 | Vascular implant detacher, electronic, single-use | A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06958698011690 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203625 | 000 |