FDA.reportPublic FDA data

FrostAway™

Primary DI
05407008487003
Brand
FrostAway™
Company
H & O Equipments SA
Model
FrostAway Pen cartridges
Catalog number
FROSTAWAYPEN-CA
Published
2025-05-18
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

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
15407008487017PrimaryGS10
05407008487003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1540700848701715407008487017
05407008487003054070084870035407008487003

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-248-2838cryoprobe@ho-equipments.com

Regulatory Flags#

DUNS number
370212933
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
15407008487000FrostAway™FrostAway PenFROSTAWAYPEN2025-05-19
15407008487017FrostAway™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
15407008482500CryoProbe™23g cartridges for CryoProbeS-HO-NO23-XX-S06-PR2021-04-14
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