FDA.reportPublic FDA data

truFreeze

Primary DI
00857068006112
Brand
truFreeze
Company
Csa Medical, Inc.
Model
20-00183
Catalog number
20-00183
Device description
Active Venting Catheter Qty 1
Published
2017-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K113021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113021000TRUFREEZE SYSTEM, TRUFREEZE SPRAY KITCSA Medical, Inc.2012-02-07GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857068006112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857068006112008570680061128570680061120857068006112

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 a target 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) to remove malignant or abnormal benign tissues.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Dry / Away from sunlight
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-866-481-7786service@csamedical.com

Regulatory Flags#

DUNS number
621229413
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857068006072truFreeze20-0018120-001812017-09-26
10857068006010truFreezeCD3-001C084070305012016-09-16
10857068006027truFreezeCD3-001C084070305002016-09-16
10857068006034truFreezeCD3-001ACCCC3CDT052016-09-16
10857068006102truFreeze20-0018420-001842017-09-26
10857068006119truFreeze20-0018320-001832017-10-05
00857068006143truFreeze20-0017720-001772019-07-15
00857068006006truFreezeCC3-01CC3-012016-09-16
00857068006013truFreezeCD3-001C084070305012016-09-16
00857068006020truFreezeCD3-001C084070305002016-09-16
00857068006037truFreezeCD3-001ACCCC3CDT052016-09-16
00857068006044truFreezeCD3-001C084070305002016-09-16
00857068006075truFreeze20-0018120-001812017-09-26
00857068006082truFreeze20-0018020-001802017-10-05
00857068006099truFreeze20-0017720-001772017-09-26
00857068006105truFreeze20-0018420-001842017-09-26
10857068006058truFreezeCD6-001ACC-CDT042017-03-14
00857068006051truFreezeCD6-001ACC-CDT042017-03-14
00857068006068truFreezeCD6-001CD6-0012017-03-14

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