ORIGEN™ EL ICD VR

GUDID 00802526535024

Implantable Cardioverter Defibrillator VR

BOSTON SCIENTIFIC CORPORATION

Single-chamber implantable defibrillator

• Primary Device ID: 00802526535024
• NIH Device Record Key: 16ec2b4e-d7b6-4902-a1d0-c2399f127e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORIGEN™ EL ICD VR
• Version Model Number: D050
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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	00802526535024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960040

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2017-11-07

On-Brand Devices [ORIGEN™ EL ICD VR]

• 00802526535024: Implantable Cardioverter Defibrillator VR
• 00802526534140: Implantable Cardioverter Defibrillator VR