FDA.reportPublic FDA data

CryotopCL(R)

Primary DI
14582231461964
Brand
CryotopCL(R)
Company
KITAZATO CORPORATION
Model
CryotopCL(G)
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQKLABWARE, ASSISTED REPRODUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14582231461964PackageGS110In Commercial Distribution
04582231461967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223146196414582231461964
04582231461967045822314619674582231461967

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction vitrification carrierA sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
711091157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573316385353KITAZATO VACUUM LINEAPL-F120611602026-03-13
14573316385367KITAZATO VACUUM LINEAPL-F150611612026-03-13
04573316385377KITAZATO VACUUM LINEAPL-F180611622026-03-13
04573316388538KITAZATO VACUUM LINEAPL-F240611642026-03-13
14580745043782ET CATHETER RYDENET-C3025PMOS-G20ASRT2133752025-09-17
14580745043904ET CATHETER RYDENET-C3022PMOS-G17ASRT2133522025-09-17
14580745044239ET CATHETER RYDENET-C3022PMOS+G17ASRT2233522025-09-17
14580745044246ET CATHETER RYDENET-C3025PMOS+G20ASRT2233752025-09-17
14573316384773Ultra-Fast WarmVT602USUF-TSx4912572025-08-28
14573316385107Ultra-Fast VitriVT601USUF-ESx4912602025-08-28
14573316385114Ultra-Fast VitriVT601USUF-VSx4912612025-08-28
14573316385978Ultra-Fast VitriVT601USUF-ES4x4912662025-08-28
14573316385985Ultra-Fast VitriVT601USUF-VS4x4912672025-08-28
14573316386012Ultra-Fast VitriVT601USUF912682025-08-28
14573316386029Ultra-Fast VitriVT601USUF-4912692025-08-28
14573316386173ES(Equilibration Solution) Pack 4 vialsVT601US-ESx4912392024-10-17
14573316385480BS(Basic Solution) Pack 4 vialsVT601US-BSx4912382024-10-17
14573316385497ES(Equilibration Solution) Pack 4 vialsVT601US-ESx4912392024-10-17
14573316385503VS(Vitrification Solution) Pack 4 vialsVT601US-VSx4912402024-10-17
14573316385510BS(Basic Solution) Pack 4 vials 4mlVT601US-BS4x4912412024-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770315Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770322Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770339Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
00888937027945ZyMotCoopersurgical, Inc.MQK2026-01-23
00888937027952ZyMotCoopersurgical, Inc.MQK2026-01-23
B056CLRCTLG2CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG2S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
00810195240002cryo-GO Vitrification Device - Red (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240033cryo-GO Vitrification Device - Green (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240040cryo-GO Vitrification Device - Purple (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240057cryo-GO Vitrification Device - Red (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240064cryo-GO Vitrification Device - Yellow (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240071cryo-GO Vitrification Device - Blue (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240088cryo-GO Vitrification Device - Green (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240095cryo-GO Vitrification Device - Purple (Pack of 50)IRVINE SCIENTIFIC, LLCMQK2025-06-02
24719874742267LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-04-10
25070002516204SpermAlignCYTOSWIM LTDMQK2025-03-03
14719874742222LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
14719874742239LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
14719874742253LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
14719874742284LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742229LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742236LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742250LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742281LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
00857515006658cryo-GO Vitrification DeviceFUJIFILM IRVINE SCIENTIFIC, INC.MQK2024-10-23