Bipolar Stimulating Probe
- Primary DI
- 00763000842567
- Brand
- Bipolar Stimulating Probe
- Company
- MEDTRONIC XOMED, INC.
- Model
- 8225451
- Device description
- PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
- Published
- 2024-10-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| ETN | STIMULATOR, NERVE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K873964 | 000 | NICOLET DISPOSABLE PRASS PROBE | Nicolet Biomedical Instruments | 1987-11-20 | ETN |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20763000842561 | Primary | GS1 | 0 | |
| 00763000842567 | Unit of Use | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Nerve-locating system probe, single-use | A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device. |
Contacts
| Phone | Email |
|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
Regulatory Flags
- DUNS number
- 835465063
- Device count
- 5
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10860013827103 | Evala nerve stimulator | Epineuron Technologies Inc. | ETN | 2026-03-17 |
| 00199150023851 | N/A | MEDTRONIC XOMED, INC. | ETN | 2026-02-16 |
| 00199150023868 | N/A | MEDTRONIC XOMED, INC. | ETN | 2026-02-16 |
| 00199150023875 | N/A | MEDTRONIC XOMED, INC. | ETN | 2026-02-16 |
| 00199150023882 | N/A | MEDTRONIC XOMED, INC. | ETN | 2026-02-16 |
| 00840067103029 | Zenith | CADWELL INDUSTRIES, INC. | ETN | 2025-12-31 |
| 00810155862664 | NONE | Neurovision Medical Products, Inc. | ETN | 2025-12-19 |
| 00810155862688 | NONE | Neurovision Medical Products, Inc. | ETN | 2025-12-19 |
| 08720791377717 | Inomed | Technomed Engineering B.V. | ETN | 2025-12-10 |
| 08720791377724 | Inomed | Technomed Engineering B.V. | ETN | 2025-12-10 |
| 08720791377731 | Inomed | Technomed Engineering B.V. | ETN | 2025-12-10 |
| 00643169547087 | NIM® | MEDTRONIC XOMED, INC. | ETN | 2025-09-13 |
| 00763000831479 | NIM™ | MEDTRONIC XOMED, INC. | ETN | 2025-08-11 |
| 20763000831480 | NIM™ | MEDTRONIC XOMED, INC. | ETN | 2025-08-11 |
| 20763000831497 | NIM™ | MEDTRONIC XOMED, INC. | ETN | 2025-08-11 |
| 14250307612076 | N/A | inomed Medizintechnik GmbH | ETN | 2025-05-02 |
| 14250307612083 | N/A | inomed Medizintechnik GmbH | ETN | 2025-05-02 |
| 00816312027570 | Rhythmlink® | RHYTHMLINK INTERNATIONAL, LLC | ETN | 2025-03-21 |
| B066HGELS1 | NONE | NEUROVISION MEDICAL PRODUCTS, INC. | ETN | 2025-02-12 |
| B006IJCBFB60 | NONE | NEUROVISION MEDICAL PRODUCTS, INC. | ETN | 2025-02-12 |
| 00763000835330 | NIM Neuro | MEDTRONIC XOMED, INC. | ETN | 2025-01-23 |
| 00190376530024 | SafeOp 3 | ALPHATEC SPINE, INC. | ETN | 2024-11-12 |
| 00763000842543 | Bipolar Stimulating Probe | MEDTRONIC XOMED, INC. | ETN | 2024-10-26 |
| 00763000842550 | Bipolar Stimulating Probe | MEDTRONIC XOMED, INC. | ETN | 2024-10-26 |
| 00763000891862 | ENT NIM Electrode | MEDTRONIC XOMED, INC. | ETN | 2024-09-23 |
| 00763000891879 | ENT NIM Electrode | MEDTRONIC XOMED, INC. | ETN | 2024-09-23 |
| 00763000580483 | ENT NIM Vital | MEDTRONIC XOMED, INC. | ETN | 2024-09-19 |
| 00763000576769 | N/A | MEDTRONIC XOMED, INC. | ETN | 2024-09-14 |
| 00763000576776 | N/A | MEDTRONIC XOMED, INC. | ETN | 2024-09-14 |
| 00887482176863 | Bovie | SYMMETRY SURGICAL INC. | ETN | 2024-08-27 |