Sperm Freeze 92215

GUDID 14573316381345

Sperm Freeze, 0.5ml x5

KITAZATO CORPORATION

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium 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