FDA.reportPublic FDA data

VitaVitro

Primary DI
06971982050021
Brand
VitaVitro
Company
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Model
ZG-1.0
Published
2018-12-05
Public version status
Update
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
K180073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180073000Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw SetShenzhen Vitavitro Bio-Tech Co., Ltd.2018-08-29MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971982050028PackageGS13In Commercial Distribution
26971982050025PackageGS15In Commercial Distribution
06971982050021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697198205002816971982050028
2697198205002526971982050025
06971982050021069719820500216971982050021

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

Regulatory Flags#

DUNS number
544504573
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971982050328VitaVitroET-A2024-08-26
06971982050335VitaVitroET-S2024-08-26
06971982050342VitaVitroET-SI2024-08-26
06971982051066VitaVitroET-I2024-08-26
06971982051073VitaVitroET-IH2024-08-26
06971982050397VitaVitroCulture Oil, Oil-1.0, 60mlV0090602022-12-22
06971982050403VitaVitroCulture Oil, Oil-1.0,125mlV009125 2022-12-22
06971982050410VitaVitroCulture Oil, Oil-1.0,500 mlV0095002022-12-22
06971982050489VitaVitroMicromanipulation Pipettes, ICSI Pipette2022-12-22
06971982050496VitaVitroMicromanipulation Pipettes, Holding Pipette2022-12-22
06971982050502VitaVitroMicromanipulation Pipettes, Biopsy Pipette2022-12-22
06971982050519VitaVitroMicromanipulation Pipettes, Denuding Pipette2022-12-21
06971982050298VitaVitroORNS-17G2024-12-06
06971982050304VitaVitroORNS-18G2024-12-06
06971982050311VitaVitroORND-17G2024-12-06
06971982050526VitaVitroCulture Dish 35 mm,10 sets/pack2022-12-21
06971982050533VitaVitroCulture Dish 60 mm,10 sets/pack2022-12-21
06971982050540VitaVitroCulture Dish 90 mm, 10 sets/pack2022-12-21
06971982050557VitaVitro Culture Dish 100mm, 10 sets/pack2022-12-21
06971982050564VitaVitro Culture Dish, Central Well Culture Dish, 1 sets/p2022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843277100093SwimCount® HarvesterMotilitycount ApSMQK2026-07-07
00843277100109SwimCount® HarvesterMotilitycount ApSMQK2026-07-07
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