Identity
- Trade Name
- MYO/Wire® Ultra-Thin Temporary Pacing Wires FDA UDI
- Generic Name
- Transthoracic pacing lead FDA UDI
- Model / Reference
- BM604ABBSTR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718627410264 FDA UDI
- 510(k) Number
- K033858 FDA UDI
- FDA Product Code
- LDF FDA UDI
- GMDN Term
- Transthoracic pacing lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3680 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transthoracic pacing lead
MYO/Wire® Ultra-Thin Temporary Pacing Wires by A & E Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K033858 also covers:
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
- MYO/Wire® Ultra-Thin Temporary Pacing Wires — A & E MEDICAL CORPORATION
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
- A & E Medical Corporation
Sources (1)
- FDA UDI 1ec1a5b6-b0df-4153-b032-05de217b93a9 33 fields · synced Jun 7, 2026