FDA UDI
In Commercial Distribution
🇺🇸 United States
TeDan Surgical Innovations
DI: 08718375868256
·
Model: ML-0445
·
Technomed Engineering B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TeDan Surgical Innovations
- Primary DI
- 08718375868256
- Version / Model
- ML-0445
- Company Name
- Technomed Engineering B.V.
- Labeler DUNS
- 418415568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-24
- Public Version
- 4
- Public Version Date
- 2025-02-17
- Public Version Status
- Update
- Public Device Record Key
- 0520aa3b-85fa-4d9f-9e26-d2c909c39cfc
Device Description
Disposable Stimulation Clip, 4.5-22mm range
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 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 |
|---|---|---|---|---|---|---|
| Package | 08718375868249 | GS1 | Shelfbox | 1 | In Commercial Distribution | |
| Primary | 08718375868256 | GS1 |
Customer Contacts
- Phone
- +31434086868
- [email protected]