ICSI Dish

GUDID 27350025914538

Hertart ApS

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
• PUD: Labware, Assisted Reproduction, Exempt

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