FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tech-Med
DI: 00665973016818
·
Model: 6023
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tech-Med
- Primary DI
- 00665973016818
- Version / Model
- 6023
- Catalog Number
- 6023
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- c32b76d3-db50-48b6-80cd-f8b32d79418f
- Distribution End Date
- 2018-11-06
Device Description
FA5050 Electrode
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
- Yes
- 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 |
|---|---|---|---|---|
| GXY | ELECTRODE, CUTANEOUS | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61020 | Analytical non-scalp cutaneous electrode | An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20665973016812 | GS1 | Case | 400 | Not in Commercial Distribution | 2018-11-06 |
| Primary | 00665973016818 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062675 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1.4 | Kilogram |