FDA.reportPublic FDA data

cryo-GO Vitrification Device

Primary DI
00857515006702
Brand
cryo-GO Vitrification Device
Company
FUJIFILM IRVINE SCIENTIFIC, INC.
Model
70312-R
Catalog number
70312-R
Device description
Red Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocysts stage embryos.
Published
2024-10-23
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

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
K241341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241341000cryo-GO Vitrification DeviceFujifilm Irvine Scientific2024-09-26MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857515006702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857515006702008575150067028575150067020857515006702

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004375706tmrequest@irvinesci.com

Regulatory Flags#

DUNS number
057475246
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893727002200Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-100mL901282016-09-10
00893727002361ISolate®99264-2x50mL992642016-09-10
00893727002903Human Serum Albumin Solution9988-100mL99882016-09-10
00893727002002Oil for Embryo Culture9305-100mL93052016-09-10
00893727002019PBS 1X - Dulbecco's Phosphate Buffered Saline Solution9235-500mL92352016-09-10
00893727002071Sperm Washing Medium9983-100mL99832016-09-10
00893727002088Sperm Washing Medium9983-12X12mL99832016-09-10
00893727002101Human Serum Albumin Solution9988-12X5mL99882016-09-10
00893727002125Hyaluronidase Solution90101-5X1mL901012016-09-10
008937270021637% PVP Solution with HSA90121-5X0.5mL901212016-09-10
0089372700217010% PVP Solution with HSA90123-5X0.5mL901232016-09-10
00893727002217Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20X5mL901282016-09-10
00893727002354ISolate®99264-12X6mL992642016-09-10
00893727002378ISolate® Concentrate99306-100ml993062016-09-10
00893727002781Oil for Embryo Culture9305-500mL93052016-09-10
00893727002859ISolate® Stock Solution99275-100ML992752016-09-10
00893727002194Modified HTF Medium-HEPES with Gentamicin90126-100mL901262016-09-10
00893727002804HTF Medium with Gentamicin90125-100mL901252016-09-10
00893727002910HTF Medium with Gentamicin90125-500mL901252016-09-10
00893727002927Modified HTF Medium-HEPES with Gentamicin90126-500mL901262016-09-10

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Primary DI, Brand, Company table
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