FDA.reportPublic FDA data

Warming System-unit, Cryosurgical

Primary DI
07290016936223
Brand
Warming System-unit, Cryosurgical
Company
UC-CARE LTD
Model
FPRMC00034
Catalog number
FPRMC00034
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07290016936223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016936223072900169362237290016936223

GMDN Terms#

Term, Definition table
TermDefinition
Cryosurgical setA sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649551124
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016936278SmartBxFPRMC00037FPRMC000372026-03-29
07290016936322Box of 80 SmartBx Disposable CassettesFPRPR00011FPRPR000112026-03-29
07290016936339Box of 10 SmartBx Disposable Needle CribsFPRPR00012FPRPR000122026-03-29
07290016936360SmartBx Spare partsFPRMC00031FPRMC000312026-03-29
07290016936001Navigo™ Workstation FPRMC0016AFPRMC0016A2017-11-15
07290016936018Computer (Industrial)FPRCO00011FPRCO000112017-11-15
07290016936025Probe sensor assembly for BK 8808 (square)FPRSA00006FPRSA000062017-11-15
07290016936032Probe sensor assembly for BK 8818 and 8808e (square)FPRSA00007FPRSA000072017-11-15
07290016936049Probe sensor assembly for Hitachi V53W (square)FPRSA00008FPRSA000082017-11-15
07290016936056Probe sensor assembly for GE E8CS (square)FPRSA00009FPRSA000092017-11-15
07290016936063Probe sensor assembly for BK 8667 (square)FPRSA00011FPRSA000112017-11-15
07290016936070Probe sensor assembly for MindRayFPRSA00013FPRSA000132017-11-15
07290016936087Probe sensor assembly for GE E8CS FPRSA00014FPRSA000142017-11-15
07290016936094Probe sensor assembly for Hitachi V53W FPRSA00012FPRSA000122017-11-15
07290016936100Ascension transmitter Cubic AssemblyASMCH00034ASMCH000342017-11-15
07290016936117Roll Stand + Arm HRDGN00023HRDGN000232017-11-15
07290016936124Probe sensor assembly for EndoCareFPRSA00015FPRSA000152017-11-15
07290016936131Probe sensor assembly for D&K 8848FPRSA00016FPRSA000162017-11-15
07290016936148Probe sensor assembly for Civco 8848FPRSA00017FPRSA000172017-11-15
07290016936155Probe sensor assembly for Hitachi EUP-U533FPRSA00018FPRSA000182017-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00194346615124EquateWAL-MART STORES, INC.GEH2025-12-22
10888853004836Freeze Away Pinpoint Skin Tag RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-10-01
10888853004867Freeze Away Sub Zero Wart RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-09-10
06935650602042HYGEAHygea Medical Technology Co., Ltd.GEH2025-09-08