Kitazato OPU Reduced Needle Type3-v1 341300

GUDID 14580303269159

KITAZATO CORPORATION

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 14580303269159
• NIH Device Record Key: d1031950-d4a3-4cb1-ada7-d4b017e66e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato OPU Reduced Needle Type3-v1
• Version Model Number: 341300 Type3-v1
• Catalog Number: 341300
• 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	04580303269152 [Primary]
GS1	14580303269159 [Package]; Contains: 04580303269152; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112462

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: 4
• Public Version Date: 2020-01-08
• Device Publish Date: 2016-11-09

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• 14573316385558 - DS(Diluent Solution) Pack 4 vials: 2024-10-25 DS(Diluent Solution) Pack of 4x4ml vials