Sperm Freeze 92215

GUDID 14573316381345

Sperm Freeze, 0.5ml x5

KITAZATO CORPORATION

IVF medium

• Primary Device ID: 14573316381345
• NIH Device Record Key: 31d435a7-bd2a-456b-85c2-3b6724e76940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sperm Freeze
• Version Model Number: Sperm Freeze
• Catalog Number: 92215
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573316381348 [Primary]
GS1	14573316381345 [Package]; Contains: 04573316381348; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192845

FDA Product Code

• MQL: MEDIA, REPRODUCTIVE

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: 2023-05-31
• Device Publish Date: 2023-01-13

On-Brand Devices [Sperm Freeze]

• 14573316381345: Sperm Freeze, 0.5ml x5
• 14573316381338: Sperm Freeze, 10ml x6
• 04573316381324: Sperm Freeze, 10ml