ICSI Dish

GUDID 27350025914538

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 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 ID: 27350025914538
• NIH Device Record Key: 764d097d-1e7d-4488-b816-49de86741b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICSI Dish
• Version Model Number: 16006
• Company DUNS: 305164017
• Company Name: Hertart ApS
• Device Count: 400
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025914534 [Unit of Use]
GS1	27350025914538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123641

FDA Product Code

• MQK: Labware, Assisted Reproduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-15

Devices Manufactured by Hertart ApS

• 17350025914579 - Sample Tube 5 mL: 2021-06-14
• 17350025914562 - Sperm Collection Container: 2021-05-10
• 17350025914616 - Pasteur Pipette 1 mL: 2020-12-30
• 17350025914623 - Pasteur Pipette 3 mL: 2020-12-30
• 07350025914541 - Collection Dish 90 mm: 2020-06-08
• 07350025914558 - Oocyte Collection Tube 14 mL: 2020-06-08
• 27350025914590 - Centrifuge Tube 15 mL: 2020-06-08
• 27350025914606 - Centrifuge Tube 50 mL: 2020-06-08