Inoue Balloon Catheter

GUDID 14960685200047

TORAY INDUSTRIES,INC.

Cardiac valvuloplasty catheter
Primary Device ID14960685200047
NIH Device Record Keyfaf259ab-d13a-4840-9f28-5151721aa24d
Commercial Distribution StatusIn Commercial Distribution
Brand NameInoue Balloon Catheter
Version Model NumberPTMC-28
Company DUNS690535422
Company NameTORAY INDUSTRIES,INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2815872299
Emailxxx@xxx.xxx
Phone2815872299
Emailxxx@xxx.xxx
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray
Phone2815872299
Emailorders_med.tiam.mb@mail.toray

Device Dimensions

Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter
Device Size Text, specify0
Catheter Gauge12 French
Length70 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.
Special Storage Condition, SpecifyBetween 0 and 0 *The device should be stored at room temperature in a dark place.

Device Identifiers

Device Issuing AgencyDevice ID
GS114960685200047 [Primary]

FDA Product Code

MADCatheter, Percutaneous (Valvuloplasty)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-17

On-Brand Devices [Inoue Balloon Catheter]

14960685200054PTMC-30
14960685200047PTMC-28
14960685200030PTMC-26

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