FDA UDI
In Commercial Distribution
🇺🇸 United States
Chalgren
DI: 00816020020801
·
Model: 295-2-36STP
·
CHALGREN ENTERPRISES
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chalgren
- Primary DI
- 00816020020801
- Version / Model
- 295-2-36STP
- Catalog Number
- 295-2-36STP
- Company Name
- CHALGREN ENTERPRISES
- Labeler DUNS
- 085932630
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 1e1cb5bc-aff3-4e1c-b47d-d1f7822a3b2b
Device Description
Reusable Finger Clip Electrode, EMG, 36 inch Shielded Leadwire
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 35750 | Analytical non-scalp cutaneous lead | An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG) and is not a dedicated neuromuscular transmission (NMT) lead set. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816020020801 | GS1 |
Customer Contacts
- Phone
- 408-847-3994
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925706 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 36 | Inch |