FDA UDI
In Commercial Distribution
🇺🇸 United States
Mini-Bolt System
DI: 00816589021585
·
Model: 22002
·
MONTERIS MEDICAL INC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mini-Bolt System
- Primary DI
- 00816589021585
- Version / Model
- 22002
- Catalog Number
- FFD-016
- Company Name
- MONTERIS MEDICAL INC
- Labeler DUNS
- 021415875
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-02
- Public Version
- 1
- Public Version Date
- 2024-01-10
- Public Version Status
- New
- Public Device Record Key
- f2b51fbe-367c-43d8-849c-fe881698a106
Device Description
NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| ONO | Neurosurgical Laser With Mr Thermography | General, Plastic Surgery | 878.4810 | 2 |
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62268 | MRI-guided laser interstitial thermal therapy system beam guide | A sterile, invasive, probe-like device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to direct and deliver laser energy for ablation of soft-tissue brain lesions. It is stereotactically placed by a neurosurgeon, using minimally-invasive techniques, and is manoeuvred during laser therapy by a remotely-controlled robotic arm/driver. It typically consists of fibreoptic materials with a laser-firing distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816589021585 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.6 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged