FDA.reportPublic FDA data

G-Vitri™ Vitrification Straw

Primary DI
06976438303256
Brand
G-Vitri™ Vitrification Straw
Company
Gimbo Medical Technology Shenzhen Co., Ltd.
Model
SC-C-B
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K240002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240002000G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.2024-06-14MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976438303256PrimaryGS10
06976438303102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976438303256069764383032566976438303256
06976438303102069764383031026976438303102

GMDN Terms#

Term, Definition table
TermDefinition
Tissue cryostorage strawA long, thin, tubular sterile device in the form of a straw used for the placement and storage of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It is made of materials to withstand storage in LN2 and is available in a variety of designs that may include a sliding plug or a permeable membrane plug to hold the sample. The sample is inserted into one end of the device and both ends are sealed, typically by using a thermal sealing device, creating an airtight seal to protect the sample from direct contact with the LN2. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
722458269
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976438300279Sperm Freezing MediumSFM102025-01-20
06976438300385Single Step Medium PlusEM302025-01-20
06976438300392Single Step Medium PlusEM602025-01-20
06976438300408Sperm Freezing MediumSFM302025-01-20
06976438300033Oocyte Flushing & Retrieval MediumORRM602024-06-25
06976438300040Oocyte Flushing & Retrieval MediumORRM1252024-06-25
06976438300057Oocyte Flushing & Retrieval MediumORRM2502024-06-25
06976438300064Oocyte Flushing & Retrieval MediumORRM5002024-06-25
06976438300071Gamete BufferGB602024-06-25
06976438300088Gamete BufferGB1252024-06-25
06976438300095Gamete BufferGB2502024-06-25
06976438300101Gamete BufferGB5002024-06-25
06976438300118Giftlife™ Fertilization MediumFM102024-06-25
06976438300125Giftlife™ Fertilization MediumFM302024-06-25
06976438300132Giftlife™ Fertilization MediumFM602024-06-25
06976438300149Giftlife™ Cleavage MediumCM102024-06-25
06976438300156Giftlife™ Cleavage MediumCM302024-06-25
06976438300163Giftlife™ Cleavage MediumCM602024-06-25
06976438300170Giftlife™ Blastocyst MediumBM102024-06-25
06976438300187Giftlife™ Blastocyst MediumBM302024-06-25

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