Identity
- Trade Name
- Micropace FDA UDI
- Generic Name
- Cardiac electrophysiology stimulation system FDA UDI
- Device Name
- Stimulus Generator Unit for EPS320 Family of Cardiac Stimulator Reconfigurable systems of EPS320B, StimCor, StimLab and ORLab FDA UDI
- Model / Reference
- Stimulus Generator Unit FDA UDI
- Description
- Stimulus Generator Unit for EPS320 Family of Cardiac Stimulator Reconfigurable systems of EPS320B, StimCor, StimLab and ORLab FDA UDI
Identifiers
- Catalog Number
- MP3008 FDA UDI
- Primary DI / UDI-DI
- 09349714004708 FDA UDI
- FDA Product Code
- JOQ FDA UDI
- GMDN Term
- Cardiac electrophysiology stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1750 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac electrophysiology stimulation system
Micropace by Micropace Pty Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Micropace Pty Limited
Sources (1)
- FDA UDI 2e4b743b-3608-4441-8b16-1998e63d354f 36 fields · synced May 29, 2026