FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 20613994910787
·
Model: DSE0003
·
MEDTRONIC XOMED, INC.
Product Codes
6
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- NA
- Primary DI
- 20613994910787
- Version / Model
- DSE0003
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-04-30
- Public Version
- 4
- Public Version Date
- 2021-02-24
- Public Version Status
- Update
- Public Device Record Key
- f8e8405d-42c9-4064-8cc8-e9f6a91fd743
Device Description
LEAD WIRE DSE0003 10PK 1.2M RED EXT ROHS
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
- No
- 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 |
|---|---|---|---|---|
| GWE | STIMULATOR, PHOTIC, EVOKED RESPONSE | Neurology | 882.1890 | 2 |
| IYN | System, imaging, pulsed doppler, ultrasonic | Radiology | 892.1550 | 2 |
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE | Neurology | 882.1900 | 2 |
| GWQ | Full-montage Standard Electroencephalograph | Neurology | 882.1400 | 2 |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35751 | Transcutaneous electrical stimulation lead | A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20613994910787 | GS1 | ||||
| Unit of Use | 00613994910783 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061639 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.2 | Meter |