Identity
- Trade Name
- Microblate Flex FDA UDI
- Generic Name
- Microwave ablation system probe, non-powered FDA UDI
- Device Name
- The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm FDA UDI
- Model / Reference
- AB1 Instrument FDA UDI
- Description
- The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm FDA UDI
Identifiers
- Catalog Number
- 7-AB1-001 FDA UDI
- Primary DI / UDI-DI
- 05060359560209 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system probe, non-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 1.00 Meter FDA UDIOuter Diameter — 2.00 Millimeter FDA UDI
Category: Microwave ablation system probe, non-powered
Microblate Flex by Creo Medical, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Creo Medical, Ltd.
Sources (2)
- FDA UDI 3200404d-50c1-4472-9161-093597e1d67f 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026