FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NeuroBlate® Advanced Probe Driver
DI: 00816589020083
·
Model: 20369
·
MONTERIS MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroBlate® Advanced Probe Driver
- Primary DI
- 00816589020083
- Version / Model
- 20369
- Catalog Number
- NBD-01
- 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
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 79ad7c98-399c-4944-b86f-a6d219df17f7
- Distribution End Date
- 2020-12-31
Device Description
Probe Driver - AXiiiS (Long)
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 Conditional
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 62269 | MRI-guided laser interstitial thermal therapy system beam guide driver | A sterile robotic device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to facilitate remote manoeuvring of an invasive laser beam guide during laser therapy to ablate soft-tissue brain lesions. It is noninvasively attached to the skull (typically via a stereotactic frame or an implanted skull anchor) whereby it rotates and translates a connected laser beam guide. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816589020083 | GS1 |
Customer Contacts
- Phone
- +1(866)799-7655
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Axiiis (Long) |