Kitazato OPU Two-Stage Reduced Needle, Type4-v1 381302

GUDID 14580303269340

KITAZATO CORPORATION

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 14580303269340
• NIH Device Record Key: 7ce10098-1dc2-4d94-bece-f011b03b1192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato OPU Two-Stage Reduced Needle, Type4-v1
• Version Model Number: 381302 Type4-v1
• Catalog Number: 381302
• 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	04580303269343 [Primary]
GS1	14580303269340 [Package]; Contains: 04580303269343; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162881

FDA Product Code

• MQE: NEEDLE, 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: 2020-01-08
• Device Publish Date: 2018-05-30

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