FDA.reportPublic FDA data

VitaVitro

Primary DI
06971982051066
Brand
VitaVitro
Company
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Model
ET-I
Published
2024-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQFCatheter, Assisted Reproduction

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240307000VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd.2024-08-16MQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971982051066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971982051066069719820510666971982051066

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction transfer catheter/setA device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). 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
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
06971982050571VitaVitro Culture Dish, Central Well Culture Dish, 10 sets/2022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580745043785ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745043907ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745044232ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745044249ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745043778ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745043891ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745044263ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745044287ET CatheterKITAZATO CORPORATIONMQF2024-09-09
M803TMI1297Clear Shapeable Intrauterine Insemination catheter MEDGYN PRODUCTS, INC.MQF2024-01-03
03700111400023FRYDMAN® CLASSIC 4.5LABORATOIRE CCDMQF2023-12-05
03700111400030FRYDMAN® CLASSIC 5.5LABORATOIRE CCDMQF2023-12-05
03700111400047FRYDMAN ® SOFT WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111400061T.D.T.®SETLABORATOIRE CCDMQF2023-12-05
03700111400085INVENTCATH ECOLABORATOIRE CCDMQF2023-12-05
03700111400092STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echoLABORATOIRE CCDMQF2023-12-05
03700111400108CLASSIC ULTRASOFT 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400122ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111400139MOCK CATHETERLABORATOIRE CCDMQF2023-12-05
03700111400146CLASSIC ULTRASOFT MOCK 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400191ULTRASOFT FRYDMAN ® SET ECHOLABORATOIRE CCDMQF2023-12-05
03700111400214ULTRASOFT FRYDMAN ® SET MOCKLABORATOIRE CCDMQF2023-12-05
03700111400221ULTRASOFT FRYDMAN® SET MOCK ECHOLABORATOIRE CCDMQF2023-12-05
03700111400269FRYDMAN® ULTRASOFTLABORATOIRE CCDMQF2023-12-05
03700111400276FRYDMAN®ULTRASOFT ECHOLABORATOIRE CCDMQF2023-12-05
03700111400290CLASSIC ULTRASOFT 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400306CLASSIC ULTRASOFT MOCK 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400351ECHOGYN®EMBRYOVIEW M 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400368ECHOGYN® EMBRYOVIEW M MOCK 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400375ECHOGYN ® EMBRYOVIEW M 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400382ECHOGYN® EMBRYOVIEW M MOCK 18 CMLABORATOIRE CCDMQF2023-12-05