FDA.reportPublic FDA data

Maverix

Primary DI
00850084563201
Brand
Maverix
Company
SERPEX MEDICAL INC.
Model
MCB-1000-Kit
Device description
Maverix Narwhal Cryo System (MCB-1000-Kit). Convenience kit containing one (1) sterile, single-use Maverix Narwhal Cryobiopsy Probe (MCB-1000) and one (1) non-sterile Maverix Narwhal Cryo Cartridge (CC-1000, 14.3 g N2O), packaged together for opening at the point of use. Probe tip OD 0.8 mm, shaft OD 1.3 mm, working length 115 cm. For use with endoscopes and bronchoscopes having a 2.0 mm minimum working channel.
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850084563201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850084563201008500845632018500845632010850084563201

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic cryosurgical probe, single-useA flexible distal component of a cryosurgical system intended to be inserted through the working channel of an endoscope for cryoadhesion and devitalization of tissues during interventional procedures (e.g., bronchoscopy/interventional pulmonology). It is connected at the proximal end to the system control unit whereby gas expansion within the probe tip causes cooling of the tip based on the Joule-Thompson effect. It is typically intended for a variety of surgical applications (e.g., biopsy, recanalization, removal of blood clots). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep away from sunlight.
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
(888) 978-0232customercare@thoracent.com

Regulatory Flags#

DUNS number
118905661
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850084563140MaverixMCB-10002026-10-27
00850084563188MaverixCC-10002026-10-27
00860009430242Adapter SRA-2-01 SRA-2-01 2025-12-08
00860009430204Recon Steerable Sheath RSS10002025-12-08
00860009430211Compass Steerable NeedleCSN10012025-12-08
00860009430235Adapter SRA-1-01 SRA-1-012025-12-08
10860009430249Adapter SRA-2-01 SRA-2-01 2025-12-08
00860009430228Compass Steerable NeedleCSN10012023-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084563140MaverixSERPEX MEDICAL INC.GEH2026-10-27
00850084563188MaverixSERPEX MEDICAL INC.GEH2026-10-27
00860001513783CryoFreezeCryoSurgery, Inc.GEH2026-10-26
00884400819949CryoFreezeCryoSurgery, Inc.GEH2026-10-26
00860010618035Focused Cryotherapy System ConsoleFocused Cryo, Inc.GEH2026-10-08
00860010618066Focused Cryotherapy System Directional CryoprobeFocused Cryo, Inc.GEH2026-10-08
10840143912795cryoICE®ATRICURE, INC.GEH2026-09-29
10840143912801cryoICE® cryoFORM™ATRICURE, INC.GEH2026-09-29
10884450457549C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-09-05
00860001513745Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513752Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513769Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00860001513790Verruca-Freeze H+CryoSurgery, Inc.GEH2026-07-31
00884450457382C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-07-20
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23