GUDID 00802526497827

Suture Sleeves

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead suture sleeve

• Primary Device ID: 00802526497827
• NIH Device Record Key: bb6a877f-8919-423b-8d69-b2a32f991546
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6403
• 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: 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	00802526497827 [Primary]
GS1	00802526620607 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910073

FDA Product Code

• NVY: Permanent defibrillator 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: 2018-09-26
• Device Publish Date: 2018-08-26

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729037859 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037873 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037880 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037927 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037934 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729037996 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729038009 - Mardis Soft: 2025-05-19 Ureteral Stent Set
• 08714729038016 - Mardis Soft: 2025-05-19 Ureteral Stent Set