Vit Kit - Freeze NX with Gentamicin and DSS 90188

GUDID 00810195240309

Vit Kit - Freeze NX (Vitrification Kit for Freezing) with Gentamicin and DSS. Includes 3x1mL Equilibration NX-ES (white cap), 3x1mL Vitrification NX-VS (blue cap), 1x1mL Washing NX-WS (red cap)

IRVINE SCIENTIFIC, LLC

IVF medium
Primary Device ID00810195240309
NIH Device Record Key748734f5-b3ac-4575-926f-b6af92471b8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVit Kit - Freeze NX with Gentamicin and DSS
Version Model Number90188
Catalog Number90188
Company DUNS121584789
Company NameIRVINE SCIENTIFIC, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810195240309 [Primary]

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-10
Device Publish Date2025-06-02

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