PDE-GEN3

GUDID 04582389010871

HAMAMATSU PHOTONICS K.K.

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• Primary Device ID: 04582389010871
• NIH Device Record Key: 07ba8815-3ef8-4a5e-ae29-daf6ae47c9cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDE-GEN3
• Version Model Number: C13999-40
• Company DUNS: 704524537
• Company Name: HAMAMATSU PHOTONICS K.K.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582389010871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133719

FDA Product Code

• IZI: System, X-Ray, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-09
• Device Publish Date: 2023-06-01

Devices Manufactured by HAMAMATSU PHOTONICS K.K.

• 04582389010871 - PDE-GEN3: 2023-06-09
• 04582389010871 - PDE-GEN3: 2023-06-09
• 04582389010659 - NanoZoomer S360MD Slide scanner system: 2022-10-10
• 04582389010031 - PDE: 2018-07-06
• 04582389010062 - NIRO-200NX: 2018-07-06
• 04582389010093 - pde-neo: 2018-07-06
• 04582389010543 - pde-neoII: 2018-07-06