Blazer® II M0045086TK20

GUDID 08714729301585

Temperature Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 08714729301585
• NIH Device Record Key: b2863880-cee2-40aa-a23e-2b013d388d45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blazer® II
• Version Model Number: M0045086TK20
• Catalog Number: M0045086TK20
• Company DUNS: 021717889
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729301585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P920047

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-16
• Device Publish Date: 2014-09-24

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• 08714729333371: Temperature Ablation Catheter
• 08714729333364: Temperature Ablation Catheter
• 08714729302889: Temperature Ablation Catheter
• 08714729301585: Temperature Ablation Catheter
• 08714729200031: Temperature Ablation Catheter
• 08714729200024: Temperature Ablation Catheter
• 08714729200017: Temperature Ablation Catheter
• 08714729199977: Temperature Ablation Catheter
• 08714729199960: Temperature Ablation Catheter
• 08714729199953: Temperature Ablation Catheter
• 08714729199946: Temperature Ablation Catheter
• 08714729199939: Temperature Ablation Catheter
• 08714729082811: Temperature Ablation Catheter
• 08714729082439: Temperature Ablation Catheter