GUDID 00802526610615

STERILZABLE TELEMETRY WAND

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer

• Primary Device ID: 00802526610615
• NIH Device Record Key: c3733906-0265-4d31-bfe7-3b628df26fd5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6395
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00802526610615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910077

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

Sterilization

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

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-13
• Device Publish Date: 2020-05-05

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729042549 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729042570 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042587 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042594 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042600 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729154921 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729154969 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729191872 - Passport: 2024-04-05 Balloon Dilatation Catheter