FDA.reportPublic FDA data

Cryotop US(R)

Primary DI
04582231462902
Brand
Cryotop US(R)
Company
KITAZATO CORPORATION
Model
Cryotop US(R)
Catalog number
81172
Published
2018-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153027000Cryotop USKitazato Biopharma Co., Ltd.2016-03-14MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14582231462909PackageGS110In Commercial Distribution
04582231462902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223146290914582231462909
04582231462902045822314629024582231462902

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.

Regulatory Flags#

DUNS number
711091157
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573316385360KITAZATO VACUUM LINEAPL-F150611612026-03-13
04580745043785ET CATHETER RYDENET-C3025PMOS-G20ASRT2133752025-09-17
04580745043907ET CATHETER RYDENET-C3022PMOS-G17ASRT2133522025-09-17
04580745044232ET CATHETER RYDENET-C3022PMOS+G17ASRT2233522025-09-17
04580745044249ET CATHETER RYDENET-C3025PMOS+G20ASRT2233752025-09-17
04573316385353KITAZATO VACUUM LINEAPL-F120611602026-03-13
04573316385377KITAZATO VACUUM LINEAPL-F180611622026-03-13
04573316388538KITAZATO VACUUM LINEAPL-F240611642026-03-13
14573316385367KITAZATO VACUUM LINEAPL-F150611612026-03-13
04573316388910Kitazato Blastomere Biopsy MicropipetteMT-BPBM-20-30953482025-10-07
04573316388927Kitazato Blastomere Biopsy MicropipetteMT-BPBM-20-35953492025-10-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029048LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029055LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029062LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029079LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029086LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029093LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
00888937029109LifeGlobal® GPS® DishwareCoopersurgical, Inc.MQK2026-05-11
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
B056CLRCTLG1CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG1S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTLG2CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056SCLLG2S-CRYOLOCK(LG)BIOTECH INCORPORATEDMQK2025-12-08
B056CLRCTPK1CRYOLOCK(PK)BIOTECH INCORPORATEDMQK2025-10-27
B056CLRCTPR1CRYOLOCK(PR)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPK1S-CRYOLOCK (PK)BIOTECH INCORPORATEDMQK2025-10-27
B056SCLPR1S-CRYOLOCK (PR)BIOTECH INCORPORATEDMQK2025-10-27
20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
06975183900017Hariomed culture dishHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQK2025-09-30
06975183900208Hariomed humidification boxHua Yue Medical Technology Co., Ltd.MQK2025-09-30
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