Blazer Prime® XP M004P4770THK20

GUDID 08714729802389

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 ID08714729802389
NIH Device Record Keye6470966-3d26-4d0e-9cc8-68363f1ef3ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlazer Prime® XP
Version Model NumberM004P4770THK20
Catalog NumberM004P4770THK20
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729802389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-06-11
Device Publish Date2014-09-24

On-Brand Devices [Blazer Prime® XP]

08714729802389Temperature Ablation Catheter
08714729802372Temperature Ablation Catheter
08714729802365Temperature Ablation Catheter
08714729802358Temperature Ablation Catheter
08714729802341Temperature Ablation Catheter
08714729802334Temperature Ablation Catheter
08714729802327Temperature Ablation Catheter

Trademark Results [Blazer Prime]

Mark Image

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

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