FDA.reportPublic FDA data

Varian CRYOCARE TOUCH™ System

Primary DI
00810563020649
Brand
Varian CRYOCARE TOUCH™ System
Company
Varian Medical Systems, Inc.
Model
CRYO-38T
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K201588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201588000CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round IceVarian Medical Systems, Inc.2020-08-11GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810563020649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810563020649008105630206498105630206490810563020649

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, electronicAn assembly of mains electricity (AC-powered) 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 an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118097024
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856100006493Respiratory Gating for Scanners2.12026-06-05
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmGM11014100GM110141002026-06-02
00816389020191Applicator and Dilator for Proctoscope ø26 mmGM11014310GM110143102026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmGM11014410GM110144102026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014110GM110141102026-05-26
00816389028104Proctoscope ø 26 mmGM11014120GM110141202026-05-26
00816389028111Dilator for Proctoscope ø 26 mmGM11014130GM110141302026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmGM11014150GM110141502026-05-26
00816389028135Fixation ScrewGM11014160GM110141602026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmGM11014200GM110142002026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014210GM110142102026-05-26
00816389028166Proctoscope ø 30 mmGM11014220GM110142202026-05-26
00816389028173Dilator for Proctoscope ø 30 mmGM11014230GM110142302026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmGM11014250GM110142502026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014170GM110141702026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014270GM110142702026-05-26
00850800006074Vitesee5.0Vitesse 5.02024-11-01
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20

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