GLIDEACCESS RSM03

GUDID 50389701007903

GLIDEACCESS System Percutaneous Sheath Introducer Kit

TERUMO MEDICAL CORPORATION

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID50389701007903
NIH Device Record Key6a13257e-898d-47d7-9aba-5922aebea63c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLIDEACCESS
Version Model NumberRSM03
Catalog NumberRSM03
Company DUNS131489882
Company NameTERUMO MEDICAL 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

Customer Support Contacts

Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Catheter Gauge4 French
Catheter Gauge4 French
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French
Length10 Centimeter
Device Size Text, specify0
Catheter Gauge4 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100389701007908 [Primary]
GS130389701007909 [Package]
Contains: 00389701007908
Package: Shelfbox [10 Units]
In Commercial Distribution
GS150389701007903 [Package]
Contains: 30389701007909
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

DYBINTRODUCER, CATHETER
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2016-09-24

On-Brand Devices [GLIDEACCESS]

30389701007954GLIDEACCESS System Percutaneous Sheath Introducer Kit
30389701007947GLIDEACCESS System Percutaneous Sheath Introducer Kit
50389701007934GLIDEACCESS System Percutaneous Sheath Introducer Kit
30389701007923GLIDEACCESS System Percutaneous Sheath Introducer Kit
50389701007910GLIDEACCESS System Percutaneous Sheath Introducer Kit
50389701007903GLIDEACCESS System Percutaneous Sheath Introducer Kit

Trademark Results [GLIDEACCESS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLIDEACCESS
GLIDEACCESS
78636066 3160810 Live/Registered
Terumo Medical Corporation
2005-05-24

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