FDA.reportPublic FDA data

CryoProbe™

Primary DI
15407008482500
Brand
CryoProbe™
Company
H & O Equipments SA
Model
23g cartridges for CryoProbe
Catalog number
S-HO-NO23-XX-S06-PR
Published
2021-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024009000CRYOPROBEH&O Equipments, Nv/Sa2003-03-20GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25407008482507PackageGS112In Commercial Distribution
15407008482500PrimaryGS10
05407008482503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2540700848250725407008482507
1540700848250015407008482500
05407008482503054070084825035407008482503

GMDN Terms#

Term, Definition table
TermDefinition
Nitrous oxide gas cartridgeA small sealed cylinder containing pressurized nitrous oxide (N2O) gas intended to be inserted into a parent device (e.g., cryosurgical system) where the cylinder is perforated to release the gas, which typically serves as a refrigerant (Joule-Thomson effect). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888-2482838cryoprobe@ho-equipments.com

Regulatory Flags#

DUNS number
370212933
Device count
6
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15407008487000FrostAway™FrostAway PenFROSTAWAYPEN2025-05-19
15407008487017FrostAway™FrostAway Pen cartridgesFROSTAWAYPEN-CA2025-05-18
05407008487003FrostAway™FrostAway Pen cartridgesFROSTAWAYPEN-CA2025-05-18
15407008481527CryoProbe™CryoProbe XP+S-HO-CEPRPLUS-002025-03-10
15407008483514Freezpen®Freezpen 35gCL-FPU-362023-03-12
15407008481022CryoProbe™CryoProbe MS-HO-CMPR-012023-03-12
15407008481114CryoProbe™CryoProbe X+S-HO-CXPRP-022023-03-12
15407008481213CryoProbe™CryoProbe B+S-HO-CBPLUSPR-062023-03-12
15407008481312CryoProbe™CryoProbe O+S-HO-COPR-022023-03-12
15407008481510CryoProbe™CryoProbe XPS-HO-CEPR-012023-03-12
15407008483118Freezpen®Freezpen 8gCL-FPU-032023-03-12
15407008483316Freezpen®Freezpen 16gCL-FPU-192023-03-12
15407008481602CryoProbe™CryoProbe XPSS-HO-CESPR-002023-03-08
B386CLN2O8GBOX1Freezpen8g N2O cartridges for FreezpenCL-N2O-8G-BOX2016-09-24
B386SHONO23XXS06PR1CryoProbe23g N2O cartridgesS-HO-NO23-XX-S06-PR2016-09-24
B386SHONOCX12S24PR1CryoProbe8g N2O cartridgesS-HO-NOCX-12-S24-PR2016-09-24
B386SHONOCXPR12S061CryoProbe16g N2O cartridgesS-HO-NOCX-PR-12-S062016-09-24
B386SNOR101CryoProbeN2O 8g cartridges and filtersS-NOR102016-09-24
B386CLFPU020Freezpen® Freezpen 8GCL-FPU-022019-05-15
B386CLFPU180Freezpen® Freezpen 16GCL-FPU-182019-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28