ThawKit Cleave

GUDID 07350025910710

Vitrolife Sweden AB

IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit
Primary Device ID07350025910710
NIH Device Record Keya9447061-2c8c-4a17-a987-2c5b8ef28586
Commercial Distribution StatusIn Commercial Distribution
Brand NameThawKit Cleave
Version Model Number10170
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 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
GS107350025910710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-24
Device Publish Date2018-02-20

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

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