Single Stepl Culture Media 93064

GUDID 04573316381492

Single Stepl Culture Media, 50ml

KITAZATO CORPORATION

IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit IVF medium kit

• Primary Device ID: 04573316381492
• NIH Device Record Key: 31ae1e3b-418c-4988-9ffb-1b9e7aa49d33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Stepl Culture Media
• Version Model Number: Single Stepl Culture Media
• Catalog Number: 93064
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573316381492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193522

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 [Single Stepl Culture Media]

• 04573316381508: Single Stepl Culture Media, 10ml
• 04573316381492: Single Stepl Culture Media, 50ml
• 04573316381485: Single Stepl Culture Media, 10ml
• 04573316381478: Single Stepl Culture Media, 50ml