FDA.reportPublic FDA data

CRYOLOCK(PK)

Primary DI
B056CLRCTPK1
Brand
CRYOLOCK(PK)
Company
BIOTECH INCORPORATED
Model
CL-R-CT(PK)
Catalog number
CL-R-CT (PINK)
Device description
Cryolock - PINKCryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
Published
2025-10-27
Public version status
New
Distribution status
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
MQKLabware, Assisted Reproduction

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122982000CRYOLOCKBiotech, Inc.2014-01-09MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B056CLRCTPK2PackageHIBCC10In Commercial Distribution
B056CLRCTPK3PackageHIBCC2In Commercial Distribution
B056CLRCTPK7PackageHIBCC40In Commercial Distribution
B056CLRCTPK1PrimaryHIBCC0
B056CLRCTPK0Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-313-7793BIOTECH@BIODISENO.COM

Regulatory Flags#

DUNS number
080129843
Device count
5
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B056CLRCTLG1CRYOLOCK(LG)CL-R-CT(LG)CL-R-CT (LIME GREEN)2025-12-08
B056SCLLG1S-CRYOLOCK(LG)S-CL(LG)S-CL (LIME GREEN)2025-12-08
B056CLRCTLG2CRYOLOCK(LG)CL-R-CT(LG)CL-R-CT (LIME GREEN)2025-12-08
B056SCLLG2S-CRYOLOCK(LG)S-CL(LG)S-CL (LIME GREEN)2025-12-08
B056CLRCTPR1CRYOLOCK(PR)CL-R-CT(PR)CL-R-CT (PURPLE)2025-10-27
B056SCLPK1S-CRYOLOCK (PK)S-CL (PK)S-CL (PINK)2025-10-27
B056SCLPR1S-CRYOLOCK (PR)S-CL (PR)S-CL (PURPLE)2025-10-27
B056CLRCTB1Cryolock(B)CL-R-CT(B)CL-R-CT (Blue)2017-04-20
B056CLRCTC1CRYOLOCK(C)CL-R-CT(C)CL-R-CT (Clear)2017-04-21
B056CLRCTG1Cryolock(G)CL-R-CT(G)CL-R-CT (Green)2017-04-20
B056CLRCTO1CRYOLOCK(O)CL-R-CT(O)CL-R-CT (Orange)2017-04-20
B056CLRCTY1CRYOLOCK(Y)CL-R-CT(Y)CL-R-CT (Yellow)2017-04-20
B056SCLB1S-CRYOLOCK (B)S-CL (B)S-CL (BLUE)2019-04-26
B056SCLC1S-CRYOLOCK (C)S-CL (C)S-CL (CLEAR)2019-04-26
B056SCLG1S-CRYOLOCK (G)S-CL (G)S-CL (GREEN)2019-04-26
B056SCLO1S-CRYOLOCK (O)S-CL (O)S-CL (ORANGE)2019-04-26
B056SCLY1S-CRYOLOCK (Y)S-CL (Y)S-CL (YELLOW)2019-04-26
B056CLRCT1CryolockCL-R-CTCL-R-CT2016-12-13
B056CLRCT2CryolockCL-R-CTCL-R-CT2016-12-13
B056SCLB5S-CRYOLOCK (B)S-CL (B)S-CL (BLUE)2019-04-26

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
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
00810195240033cryo-GO Vitrification Device - Green (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02