Kitazato OPU Needle 328000

GUDID 14580745041801

KITAZATO CORPORATION

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 14580745041801
• NIH Device Record Key: f217fd54-a8db-47e0-bcc7-1b1fd0e14c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato OPU Needle
• Version Model Number: 328000
• Catalog Number: 328000
• 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	04580745041804 [Primary]
GS1	14580745041801 [Package]; Contains: 04580745041804; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-05
• Device Publish Date: 2022-09-27

On-Brand Devices [Kitazato OPU Needle]

• 14580745041856: 322000
• 14580745041849: 321000
• 14580745041832: 320042
• 04580745041828: 320041
• 14580745041818: 329000
• 14580745041801: 328000
• 04580745041798: 327000
• 14580745041788: 326000
• 14580745041504: 382124
• 14580745041498: 382023
• 14580745041481: 381722
• 14580745041474: 381720