FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NeuroBlate® System
DI: 00816589020311
·
Model: 20720
·
MONTERIS MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroBlate® System
- Primary DI
- 00816589020311
- Version / Model
- 20720
- Catalog Number
- NB102-R
- Company Name
- MONTERIS MEDICAL INC
- Labeler DUNS
- 021415875
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- db19d236-ffd0-4d79-bb69-bbf8247c0082
- Distribution End Date
- 2017-04-28
Device Description
NeuroBlate® System
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62267 | MRI-guided laser interstitial thermal therapy system | A mains electricity (AC-powered) device assembly intended to be used in conjunction with an MRI system to deliver laser interstitial thermal therapy (LITT) for ablation of soft-tissue brain lesions (e.g., tumours). It provides MRI-based trajectory planning assistance for the placement of an invasive laser beam guide (probe) [typically using a stereotactic frame or an implanted skull anchor], laser beam delivery, and real-time MR-based thermographic analysis to monitor therapy delivery. It includes a workstation/interface platform with display and remote robotic controls for manoeuvring laser beam delivery, a laser light and cooling CO2 source, cabling, and operation/analysis software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816589020311 | GS1 |
Customer Contacts
- Phone
- +1(866)799-7655
- [email protected]