GUDID 00802526489600

Anchoring Sleeve

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead suture sleeve

• Primary Device ID: 00802526489600
• NIH Device Record Key: 2db333d8-73a3-4329-b097-318481bf4cc1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6830
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526489600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P830060

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506055325 - OPAL HDx™: 2024-10-16 Mapping System Signal Station
• 00191506055370 - OPAL HDx™: 2024-10-16 Mapping System
• 08714729848097 - Colpassist: 2024-10-16 Vaginal Positioning Device
• 08714729784432 - Percutaneous Tract Kit: 2024-10-11 Percutaneous Tract Kit
• 08714729789536 - Lingeman Percutaneous Tract Kit: 2024-10-11 Percutaneous Tract Kit
• 08714729010944 - NA: 2024-10-10 Connecting Tube for 3F through 6F Catheters