INGEVITY™+

GUDID 00802526604430

Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet delivered

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead

• Primary Device ID: 00802526604430
• NIH Device Record Key: fe2497ca-8bf3-4283-b93f-13f29b75f486
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INGEVITY™+
• Version Model Number: 7840
• 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: true
• 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 Dimensions

• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526604430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150012

FDA Product Code

• NVN: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

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: 2020-02-14
• Device Publish Date: 2020-02-06

On-Brand Devices [INGEVITY™+]

• 00802526604577: Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet de
• 00802526604522: Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet de
• 00802526604430: Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet de