Maverix MCB-1000
Maverix MCB-1000 is an endoscopic cryosurgical probe (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Serpex Medical, Inc., listed in FDA GUDID since 27 Oct 2026 (UDI-DI 00850084563140), registry data as of 9 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850084563140 | Date27 Oct 2026 | StatusListed |
Official records
- AccessGUDID record 00850084563140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Maverix
- Generic name
- Endoscopic cryosurgical probe, single-use
- Model / reference
- MCB-1000
- Primary DI / UDI-DI
- 00850084563140
- FDA product code
- GEH
- GMDN term
- Endoscopic cryosurgical probe, single-use
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 1.3 MillimeterLength — 1150 Millimeter
Similar devices
Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).
- ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM by ENDOCARE, INC.
- SEEDNET, MODELS FP6T5, FP5T5, FP5T3 by GALIL MEDICAL LTD
- MT-700 MT-750 FT-350 by Cryomedics, Inc.
- truFreeze System by CSA Medical
- ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) by ATRICURE, INC.
- CRYOPEN CRYOSURGICAL SYSTEM, K102214 by Cryopen, Inc.
- COMPOUND W FREEZE OFF WART REMOVAL SYSTEM by OraSure Technologies, Inc.
- ISIS by GALIL MEDICAL LTD
- C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge by PENTAX of America Inc.
- ERBOKRYO CA CRYOSURGICAL SYSTEM by Erbe Elektromedizin GmbH