Cryotop US(Y) 81175

GUDID 14582231462930

KITAZATO CORPORATION

Assisted reproduction vitrification carrier

• Primary Device ID: 14582231462930
• NIH Device Record Key: 3799a18a-7718-41a1-a3f4-8b86b4d6db9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryotop US(Y)
• Version Model Number: Cryotop US(Y)
• Catalog Number: 81175
• Company DUNS: 711091157
• Company Name: KITAZATO CORPORATION
• Device Count: 1
• 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: true
• 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	04582231462933 [Primary]
GS1	14582231462930 [Package]; Contains: 04582231462933; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153027

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: 2
• Public Version Date: 2020-01-08
• Device Publish Date: 2018-07-27

Devices Manufactured by KITAZATO CORPORATION

• 14573316385480 - BS(Basic Solution) Pack 4 vials: 2024-10-25 BS(Basic Solution) Pack of 4x1.5ml vials
• 14573316385497 - ES(Equilibration Solution) Pack 4 vials: 2024-10-25 ES(Equilibration Solution) Pack 4x1.5ml vials
• 14573316385503 - VS(Vitrification Solution) Pack 4 vials: 2024-10-25 VS(Vitrification Solution) Pack of 4x1.5ml vials
• 14573316385510 - BS(Basic Solution) Pack 4 vials 4ml: 2024-10-25 BS(Basic Solution) Pack of 4x4ml vials
• 14573316385527 - ES(Equilibration Solution) Pack 4 vials 4ml: 2024-10-25 ES(Equilibration Solution) Pack 4x4ml vials
• 14573316385534 - VS(Vitrification Solution) Pack 4 vials 4ml: 2024-10-25 VS(Vitrification Solution) Pack of 4x4ml vials
• 14573316385558 - DS(Diluent Solution) Pack 4 vials: 2024-10-25 DS(Diluent Solution) Pack of 4x4ml vials
• 14573316385565 - WS(Washing Solution) Pack 4 vials: 2024-10-25 WS(Washing Solution) Pack of 4x4ml vials