Identity
- Trade Name
- Vitalitec FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- Composite handle HF connection, without ratchet FDA UDI
- Model / Reference
- L-PHS FDA UDI
- Description
- Composite handle HF connection, without ratchet FDA UDI
Identifiers
- Catalog Number
- L-PHS FDA UDI
- Primary DI / UDI-DI
- 04250325437463 FDA UDI
- 510(k) Number
- K944270 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, reusable
Vitalitec by Vitalitec International Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K944270 also covers:
- Vitalitec — Vitalitec International Medizintechnik GmbH
- Vitalitec — Vitalitec International Medizintechnik GmbH
- Vitalitec — Vitalitec International Medizintechnik GmbH
- Vitalitec — Vitalitec International Medizintechnik GmbH
- Vitalitec — Vitalitec International Medizintechnik GmbH
- Vitalitec — Vitalitec International Medizintechnik GmbH
- Vitalitec — Vitalitec International Medizintechnik GmbH
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 |
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Manufacturer
- Manufacturer
- Vitalitec International Medizintechnik GmbH
Sources (1)
- FDA UDI 25134337-66ae-4a4c-b731-f842d2d19861 35 fields · synced Jun 1, 2026