Culture Dish 60 mm

GUDID 27350025914491

Hertart ApS

Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish Assisted reproduction procedure dish
Primary Device ID27350025914491
NIH Device Record Key6b37d39e-4880-4aeb-8491-f60869bebb65
Commercial Distribution StatusIn Commercial Distribution
Brand NameCulture Dish 60 mm
Version Model Number16002
Company DUNS305164017
Company NameHertart ApS
Device Count540
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
GS107350025914497 [Unit of Use]
GS127350025914491 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-15

Devices Manufactured by Hertart ApS

17350025914579 - Sample Tube 5 mL2021-06-14
17350025914562 - Sperm Collection Container2021-05-10
17350025914616 - Pasteur Pipette 1 mL2020-12-30
17350025914623 - Pasteur Pipette 3 mL2020-12-30
07350025914541 - Collection Dish 90 mm2020-06-08
07350025914558 - Oocyte Collection Tube 14 mL2020-06-08
27350025914590 - Centrifuge Tube 15 mL2020-06-08
27350025914606 - Centrifuge Tube 50 mL2020-06-08

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