FDA UDI
In Commercial Distribution
🇺🇸 United States
VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER
DI: 03760244031402
·
Model: ROSA3-276A
·
MEDTECH
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER
- Primary DI
- 03760244031402
- Version / Model
- ROSA3-276A
- Catalog Number
- ROSAS00351
- Company Name
- MEDTECH
- Labeler DUNS
- 264502977
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-09
- Public Version
- 8
- Public Version Date
- 2024-01-08
- Public Version Status
- Update
- Public Device Record Key
- 24750315-8519-434f-8599-7d40cae32140
Device Description
VENTRICULAR ENDOSCOPY INSTRUMENT HOLDER instrument Rosa 3.0 instrument Rosa 3.1 instrument holder for guidance of neurosurgical endoscope during ventricular procedures through instrument adaptors to accomodate specific endoscope models, positionned by the robot arm in accordance with pre-operative plan.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45199 | Multi-purpose stereotactic surgery system | An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
| 32568 | Neurological stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760244031402 | GS1 |