NIM™
- Primary DI
- 20763000831497
- Company
- MEDTRONIC XOMED, INC.
- Model
- 8225825X
- Device description
- PROBE 8225825X 3PK INCREMT STD PRASS TIP
- Published
- 2025-08-11
- 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
Regulatory Flags
- DUNS number
- 835465063
- Device count
- 1
- 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
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20763000831497 | Package | GS1 | 3 | In Commercial Distribution |
| 00763000831493 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 20763000831497 | Package | GS1 | 3 | PK | 00763000831493 | | In Commercial Distribution |
| 00763000831493 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| ETN | Stimulator, Nerve | 2 | Ear, Nose, Throat | 874.1820 | N | Ineligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K213246 | 000 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | 2022-03-21 | ETN |
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. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -29 Degrees Celsius | 60 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
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|---|
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| 00763000842567 | Bipolar Stimulating Probe | MEDTRONIC XOMED, INC. | ETN | 2024-10-26 |
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