FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 20763000038261
·
Model: 8227510
·
MEDTRONIC XOMED, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- N/A
- Primary DI
- 20763000038261
- Version / Model
- 8227510
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-04-04
- Public Version
- 2
- Public Version Date
- 2021-03-01
- Public Version Status
- Update
- Public Device Record Key
- e6a9f729-e4df-4b30-a7db-ff21dc89f5e6
Device Description
ELECTRODE 8227510 5PK PR 2CH18MM 2M ROHS
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 |
|---|---|---|---|---|
| IKT | Electrode, needle, diagnostic electromyograph | Physical Medicine | 890.1385 | 2 |
| IKN | Electromyograph, diagnostic | Physical Medicine | 890.1375 | 2 |
| GXZ | ELECTRODE, NEEDLE | Neurology | 882.1350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11441 | Electromyographic needle electrode, single-use | A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20763000038261 | GS1 | ||||
| Unit of Use | 00763000038267 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024316 | 000 |