Identity
- Trade Name
- Spes Medica Subdermal Needle Electrodes FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Model / Reference
- MN4013D20B/S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18054655024729 FDA UDI
- 510(k) Number
- K192603 FDA UDI
- FDA Product Code
- GXZ FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electromyographic needle electrode, single-use
Spes Medica Subdermal Needle Electrodes by Spes Medica Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192603 also covers:
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
- Spes Medica Subdermal Needle Electrodes — SPES MEDICA SPA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spes Medica Spa
Sources (1)
- FDA UDI 591440fe-ba20-4e40-a472-337d6e618b2f 33 fields · synced May 31, 2026