Identity
- Trade Name
- ORLAB FDA UDI
- Generic Name
- Cardiac electrophysiology stimulation system FDA UDI
- Device Name
- Diagnostic cardiac computerized reconfigurable stimulator system FDA UDI
- Model / Reference
- ORLAB FDA UDI
- Description
- Diagnostic cardiac computerized reconfigurable stimulator system FDA UDI
Identifiers
- Catalog Number
- MP3192 FDA UDI
- Primary DI / UDI-DI
- 09349714004739 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
Orlab 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 d5b0a8f3-8545-40a4-a31c-dc0e01cc501e 36 fields · synced May 30, 2026