FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Dry Flex-M
DI: B675DRYFLEXM1
·
Model: ZP-200-42211
·
ZETO INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Dry Flex-M
- Primary DI
- B675DRYFLEXM1
- Version / Model
- ZP-200-42211
- Catalog Number
- ZP-200-42211
- Company Name
- ZETO INC
- Labeler DUNS
- 079582566
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-01-25
- Public Version
- 3
- Public Version Date
- 2024-12-30
- Public Version Status
- Update
- Public Device Record Key
- e32fdc11-d9d4-4916-9ced-9d2ba1e51339
- Distribution End Date
- 2023-11-10
Device Description
Dry Flex Electrode - Bristle, Medium
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 11440 | Analytical scalp electrode, single-use | A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. 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 |
|---|---|---|---|---|---|---|
| Unit of Use | B675DRYFLEXM2 | HIBCC | ||||
| Primary | B675DRYFLEXM1 | HIBCC |
Customer Contacts
- Phone
- 8339386334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172735 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Bristle, Medium |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place, away from direct sunlight