Kitazato OPU Needle Type2-v5 350354

GUDID 14580303269135

KITAZATO CORPORATION

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 14580303269135
• NIH Device Record Key: 408321d3-06b8-4635-9bd6-7c7531c8bdcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato OPU Needle Type2-v5
• Version Model Number: 350354 Type2-v5
• Catalog Number: 350354
• 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	04580303269138 [Primary]
GS1	14580303269135 [Package]; Contains: 04580303269138; 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

On-Brand Devices [Kitazato OPU Needle Type2-v5]

• 14580303269135: 350354 Type2-v5
• 14580303269128: 350304 Type2-v5