Gx-IVF

GUDID 07350025910604

Vitrolife Sweden AB

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium
Primary Device ID07350025910604
NIH Device Record Keya673c903-2a14-4541-a4fc-a3bd0199497b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGx-IVF
Version Model Number10171
Company DUNS631805488
Company NameVitrolife Sweden AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS107350025910604 [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 Date2021-05-31
Device Publish Date2021-05-21

Devices Manufactured by Vitrolife Sweden AB

07350025910901 - EmbryoGlue2022-02-07
07350025910765 - HYASE-10X2022-01-10
07350025910833 - HYASE-10X2021-07-01
07350025910796 - G-RINSE2021-06-04
07350025910802 - ASP2021-06-04
07350025910819 - G-MOPS2021-06-04
07350025910826 - G-MOPS PLUS2021-06-04
07350025910604 - Gx-IVF2021-05-31
07350025910604 - Gx-IVF2021-05-31

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