FDA UDI
In Commercial Distribution
🇺🇸 United States
NIM™
DI: 00763000831486
·
Model: 8225490X
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NIM™
- Primary DI
- 00763000831486
- Version / Model
- 8225490X
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-11
- Public Version
- 1
- Public Version Date
- 2025-08-19
- Public Version Status
- New
- Public Device Record Key
- c6ae8a86-7342-4633-bb4e-6ef87769c710
Device Description
PROBE 8225490X 3PK INCREMENTING 1MM TIP
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ETN | STIMULATOR, NERVE | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61089 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20763000831480 | GS1 | PK | 3 | In Commercial Distribution | |
| Primary | 00763000831486 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213246 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1mm Ball Tip |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius