FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SideFire® Directional Laser Probe
DI: 00816589020564
·
Model: 20368-00
·
MONTERIS MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SideFire® Directional Laser Probe
- Primary DI
- 00816589020564
- Version / Model
- 20368-00
- Catalog Number
- NBP-001-01
- Company Name
- MONTERIS MEDICAL INC
- Labeler DUNS
- 021415875
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ecc99657-ef4e-438e-a5c9-db5a2cd38c80
- Distribution End Date
- 2017-10-25
Device Description
3.3mm Directional 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
- 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 |
|---|---|---|---|---|
| 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 | 00816589020564 | GS1 |
Customer Contacts
- Phone
- +1(866)799-7655
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.3 | Millimeter | |
| Device Size Text, specify | Size 00 |