Geri Dish

GUDID 29348265003011

The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.

GENEA BIOMEDX PTY LTD

Assisted reproduction procedure dish
Primary Device ID29348265003011
NIH Device Record Key3930cb5b-742b-4afa-8ab8-bdc7d23f9290
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeri Dish
Version Model NumberGERI-DSH-20
Company DUNS752103403
Company NameGENEA BIOMEDX PTY LTD
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
GS109348265003017 [Primary]
GS119348265003014 [Package]
Contains: 09348265003017
Package: [20 Units]
In Commercial Distribution
GS129348265003011 [Package]
Contains: 19348265003014
Package: [24 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 Number4
Public Version Date2021-03-10
Device Publish Date2017-12-08

Devices Manufactured by GENEA BIOMEDX PTY LTD

29348265003011 - Geri Dish2021-03-10The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
29348265003011 - Geri Dish2021-03-10 The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used
09348265003048 - Geri Water Bottle2019-10-23 The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
09348265003024 - Geri Connect Server (including software)2019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m
09348265003079 - Geri Software Connect and Assess 1.32019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m
09348265003086 - Geri Software Connect and Assess 2.02019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m

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