Identity
- Trade Name
- GE FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- RADIOTRANSLUCENT LEADWIRE FDA UDI
- Model / Reference
- 2003424-001 FDA UDI
- Description
- RADIOTRANSLUCENT LEADWIRE FDA UDI
Identifiers
- Catalog Number
- 2003424-001 FDA UDI
- Primary DI / UDI-DI
- 10653405002642 FDA UDI
- 510(k) Number
- K945034 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Ge by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Conmed Corporation
Sources (1)
- FDA UDI 18225e5c-70ae-48f9-b80a-8476ca1aec98 38 fields · synced Jun 1, 2026