Sepa Sperm 40% 92041

GUDID 04573316381294

40% SepaSperm solution with Gentamicin, 50mL

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: 04573316381294
• NIH Device Record Key: d7c0ac19-8b51-43be-a080-33ba74b6ccd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sepa Sperm 40%
• Version Model Number: Sepa Sperm 40%
• Catalog Number: 92041
• 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	04573316381294 [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 40%]

• 04573316381294: 40% SepaSperm solution with Gentamicin, 50mL
• 04573316381263: 40% SepaSperm solution with Gentamicin, 100mL