S-CRYOLOCK(LG)

Primary DI
B056SCLLG2
Brand
S-CRYOLOCK(LG)
Company
BIOTECH INCORPORATED
Model
S-CL(LG)
Catalog number
S-CL (LIME GREEN)
Device description
S-Cryolock - LIME GREEN Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B056SCLLG2PackageHIBCC10In Commercial Distribution
B056SCLLG3PackageHIBCC2In Commercial Distribution
B056SCLLG1PrimaryHIBCC0
B056SCLLG0Unit 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
B056CLRCTPK1CRYOLOCK(PK)CL-R-CT(PK)CL-R-CT (PINK)2025-10-27
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
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
00810195240033cryo-GO Vitrification Device - Green (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02