Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Model / Reference
- MAJ-1607 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019778003368 FDA UDI
- FDA Product Code
- FEQ FDA UDI
- GMDN Term
- Cardiac ablation system irrigation tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac ablation system irrigation tubing set
Olympus by Keymed (Medical & Industrial Equipment), Ltd. — 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
- Keymed (Medical & Industrial Equipment), Ltd.
Sources (1)
- FDA UDI fbaf50cf-3ff3-40d6-9897-aab4ad5324f9 32 fields · synced Jun 1, 2026