FDA UDI
In Commercial Distribution
🇺🇸 United States
PULSE
DI: 00195377153807
·
Model: 5050205
·
Nuvasive, Inc.
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PULSE
- Primary DI
- 00195377153807
- Version / Model
- 5050205
- Company Name
- Nuvasive, Inc.
- Labeler DUNS
- 053950783
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-02
- Public Version
- 1
- Public Version Date
- 2023-05-10
- Public Version Status
- New
- Public Device Record Key
- 3e81c5ce-ca86-4ef3-a131-c443cdd19356
Device Description
PULSE CIOS Array, Right Large
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
- Yes
- 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 |
|---|---|---|---|---|
| ETN | STIMULATOR, NERVE | Ear, Nose, Throat | 874.1820 | 2 |
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
| IKN | Electromyograph, diagnostic | Physical Medicine | 890.1375 | 2 |
| GWF | Stimulator, electrical, evoked response | Neurology | 882.1870 | 2 |
| HAW | Neurological stereotaxic Instrument | Neurology | 882.4560 | 2 |
| OWB | Interventional fluoroscopic x-ray system | Radiology | 892.1650 | 2 |
| PDQ | Neurosurgical nerve locator | Ear, Nose, Throat | 874.1820 | 2 |
| LLZ | System, image processing, radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45200 | Orthopaedic 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 orthopaedic surgery. 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 | 00195377153807 | GS1 |
Customer Contacts
- Phone
- +1(858)909-1800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210574 | 000 |