FDA.report

Minvitro Vitrification Straw

Primary DI
06971855770322
Company
Guangzhou Hehong Biotech Co., Ltd.
Model
MVT-VSNB
Catalog number
MVT-VSNB
Published
2026-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
419557208
Device count
1
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
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
06971855770322PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
06971855770322PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MQKLabware, Assisted Reproduction2Obstetrics/Gynecology884.6160NEligible

Premarket Submissions

SubmissionSupplement
K241454000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241454000Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.2025-02-03MQK

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06971855770308Minvitro Vitrification StrawMVT-VSNRMVT-VSNR2026-03-10
06971855770315Minvitro Vitrification StrawMVT-VSNYMVT-VSNY2026-03-10
06971855770339Minvitro Vitrification StrawMVT-VSNGMVT-VSNG2026-03-10
06971855770377Minvitro Vitrification StrawMVT-VSNPMVT-VSNP2026-03-10
06971855770902Minvitro Embryo Transfer CatheterETCB20175ETCB201752026-03-10
06971855770919Minvitro Embryo Transfer CatheterETCA23175ETCA231752026-03-10
06971855770926Minvitro Embryo Transfer CatheterETCB20175-CETCB20175-C2026-03-10
06971855770933Minvitro Embryo Transfer CatheterETCA23175-CETCA23175-C2026-03-10
06971855770940Minvitro Embryo Transfer CatheterETCB20175-ETETCB20175-ET2026-03-10
06971855770957Minvitro Embryo Transfer CatheterETCB20175-ET-CETCB20175-ET-C2026-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06971855770308Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
06971855770315Minvitro 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
00857515006665cryo-GO Vitrification DeviceFUJIFILM IRVINE SCIENTIFIC, INC.MQK2024-10-23