Sepa Sperm 60% 92034

GUDID 04573316381256

60% SepaSperm solution with Gentamicin, 100mL

KITAZATO CORPORATION

IVF medium

• Primary Device ID: 04573316381256
• NIH Device Record Key: 86ac5029-82df-40b9-a70e-3e56fdd628ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sepa Sperm 60%
• Version Model Number: Sepa Sperm 60%
• Catalog Number: 92034
• 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	04573316381256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190199

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 [Sepa Sperm 60%]

• 04573316381287: 60% SepaSperm solution with Gentamicin, 50mL
• 04573316381256: 60% SepaSperm solution with Gentamicin, 100mL