Ultra ICE™ Plus - PI

GUDID 08714729982500

Peripheral Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729982500
NIH Device Record Key5311b0f2-fd52-440c-880b-13e43d38db7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra ICE™ Plus - PI
Version Model NumberH7493932800990
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

Device Dimensions

Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter
Catheter Gauge8.5 French
Length110 Centimeter
Outer Diameter2.82 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729982500 [Primary]

FDA Product Code

DXKEchocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729838005 - Capio SLIM2024-11-13 Suture Capturing Device
00191506043193 - FARAWAVE™ NAV2024-10-30 Pulsed Field Ablation Catheter
00191506043209 - FARAWAVE™ NAV2024-10-30 Pulsed Field Ablation Catheter
00191506043216 - FARAWAVE™2024-10-30 Pulsed Field Ablation Catheter
00191506043223 - FARAWAVE™2024-10-30 Pulsed Field Ablation Catheter
00191506043698 - FARASTAR™2024-10-30 Pulsed Field Ablation Generator
00191506043704 - FARASTAR™2024-10-30 Pulsed Field Ablation Generator
00191506043711 - FARASTAR™2024-10-30 Pulsed Field Ablation Generator

Trademark Results [Ultra ICE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRA ICE
ULTRA ICE
86638909 5018842 Live/Registered
Arctic Ice, LLC
2015-05-22
ULTRA ICE
ULTRA ICE
86534175 not registered Dead/Abandoned
Saint-Gobain Abrasives, Inc.
2015-02-13
ULTRA ICE
ULTRA ICE
86275694 4701423 Live/Registered
Lawrence Foods, Inc.
2014-05-08
ULTRA ICE
ULTRA ICE
78319782 2904009 Live/Registered
PLANO MOLDING COMPANY, LLC
2003-10-28
ULTRA ICE
ULTRA ICE
77932629 4202737 Live/Registered
Boston Scientific Scimed, Inc.
2010-02-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.