PeriBeam® Pericardial Membrane

GUDID 04589795950241

TAMABIO CO., LTD.

Pericardium prosthesis

• Primary Device ID: 04589795950241
• NIH Device Record Key: 85c00988-1fd6-4a0e-92f0-7dfda5420a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriBeam® Pericardial Membrane
• Version Model Number: P-090-1010
• Company DUNS: 693002116
• Company Name: TAMABIO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589795950241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240775

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-25
• Device Publish Date: 2026-03-17