CryotopUS-scoop(Y) 81199

GUDID 14582231462886

Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.

KITAZATO CORPORATION

Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier Assisted reproduction vitrification carrier
Primary Device ID14582231462886
NIH Device Record Keyf21ef9fa-35d0-475c-8f37-66a9ce7476b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryotopUS-scoop(Y)
Version Model NumberCryotopUS-scoop(Y)
Catalog Number81199
Company DUNS711091157
Company NameKITAZATO CORPORATION
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582231462889 [Primary]
GS114582231462886 [Package]
Contains: 04582231462889
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQKLABWARE, ASSISTED REPRODUCTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-08
Device Publish Date2019-06-01

Devices Manufactured by KITAZATO CORPORATION

04582231462186 - Kitazato ReproPlate-K22023-09-11 1 Packs
04582231462193 - Kitazato ReproPlate-K62023-09-11 1 Packs
04582231462209 - Kitazato ReproPlate-K32023-09-11 1 Packs
04582231462407 - Kitazato ReproPlate-K1(3Well)2023-09-11 10 Packs
04582231462414 - Kitazato ReproPlate-K22023-09-11 10 Packs
04582231462421 - Kitazato ReproPlate-K62023-09-11 10 Packs
04582231462438 - Kitazato ReproPlate-K32023-09-11 10 Packs
04582231462711 - Kitazato ReproPlate-K1(3Well)2023-09-11 1 Packs

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