FDA UDI
In Commercial Distribution
🇺🇸 United States
MedCare Visions
DI: 00816022023596
·
Model: PRO-EBW
·
IMPULSE MEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MedCare Visions
- Primary DI
- 00816022023596
- Version / Model
- PRO-EBW
- Catalog Number
- OL5100046
- Company Name
- IMPULSE MEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 080015502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-30
- Public Version
- 2
- Public Version Date
- 2024-12-30
- Public Version Status
- Update
- Public Device Record Key
- 4ddc66f7-85fd-441a-b3a0-e3de2fdb1a3a
Device Description
Disposable OL5100046 aEEG Needle Electrode Set, 12mm x29ga, 40", (Pack of 40)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47714 | Subdermal needle electrode | A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816022023596 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020910 | 000 |