ASTEC IVF ICSI Dish

GUDID 24580647510082

ASTEC CO.,LTD.

Assisted reproduction procedure dish

• Primary Device ID: 24580647510082
• NIH Device Record Key: 012b5bf3-6d05-4a98-92dc-bbed3bc777d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTEC IVF ICSI Dish
• Version Model Number: AID-ICSI
• Company DUNS: 694169152
• Company Name: ASTEC CO.,LTD.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580647510088 [Unit of Use]
GS1	14580647510085 [Primary]
GS1	24580647510082 [Package]; Contains: 14580647510085; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• PUD: Labware, Assisted Reproduction, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-09
• Device Publish Date: 2024-08-01

Devices Manufactured by ASTEC CO.,LTD.

• 24580647510051 - ASTEC IVF 4Well Dish: 2024-08-09
• 24580647510068 - ASTEC IVF 4Well Dish: 2024-08-09
• 24580647510075 - ASTEC IVF Center Well Dish: 2024-08-09
• 24580647510082 - ASTEC IVF ICSI Dish: 2024-08-09
• 24580647510082 - ASTEC IVF ICSI Dish: 2024-08-09
• 24580647510099 - ASTEC IVF 35mm Culture Dish: 2024-08-09
• 24580647510105 - ASTEC IVF 60mm Culture Dish: 2024-08-09
• 14580647510030 - Embryo Grid: 2022-10-10