Blazer Prime® HTD M004P5031THN40

GUDID 08714729803607

Temperature Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter

Primary Device ID	08714729803607
NIH Device Record Key	ef2e068e-f628-459f-afd1-cc99fc8f9a0f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Blazer Prime® HTD
Version Model Number	M004P5031THN40
Catalog Number	M004P5031THN40
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	08714729803607 [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	2020-06-11
Device Publish Date	2014-09-24

On-Brand Devices [Blazer Prime® HTD]

08714729803669	Temperature Ablation Catheter
08714729803645	Temperature Ablation Catheter
08714729803621	Temperature Ablation Catheter
08714729803614	Temperature Ablation Catheter
08714729803607	Temperature Ablation Catheter
08714729803591	Temperature Ablation Catheter

Trademark Results [Blazer Prime]

Mark Image Registration \| Serial	Company Trademark Application Date
BLAZER PRIME 77385442 3775309 Live/Registered	Boston Scientific Scimed, Inc. 2008-01-31