Adelante Radial ASR0501018B5

GUDID 10885672002159

Introducer Set with Hemostatic Valve, 5F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID10885672002159
NIH Device Record Keydf59b106-998c-43cb-b407-e7a365775c2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdelante Radial
Version Model NumberASR0501018B5
Catalog NumberASR0501018B5
Company DUNS101835833
Company NameOscor Inc.
Device Count5
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 Datetrue
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(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter
Device Size Text, specify0
Length45 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.8 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672002152 [Unit of Use]
GS110885672002159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-11-16

On-Brand Devices [Adelante Radial]

20885672004327Introducer Set with Hemostatic Valve, 6F
20885672004310Introducer Set with Hemostatic Valve, 5F
20885672004303Introducer Set with Hemostatic Valve, 4F
20885672003894Introducer Set with Hemostatic Valve, 6F
20885672003887Introducer Set with Hemostatic Valve, 5F
20885672003870Introducer Set with Hemostatic Valve, 4F
20885672000503Introducer Set with Hemostatic Valve, 6F
20885672000497Introducer Set with Hemostatic Valve, 5F
20885672000480Introducer Set with Hemostatic Valve, 4F
10885672103726Introducer Set with Hemostatic Valve, 5F
10885672103719Introducer Set with Hemostatic Valve, 4F
10885672103665Introducer Set with Hemostatic Valve, 6F
10885672006904Introducer Set with Hemostatic Valve, 6F
10885672006898Introducer Set with Hemostatic Valve, 5F
10885672003866Introducer Set with Hemostatic Valve, 6F
10885672003859Introducer Set with Hemostatic Valve, 5F
10885672003842Introducer Set with Hemostatic Valve, 4F
10885672003835Introducer Set with Hemostatic Valve, 6F
10885672003828Introducer Set with Hemostatic Valve, 5F
10885672003811Introducer Set with Hemostatic Valve, 4F
10885672003743Introducer Set with Hemostatic Valve, 6F
10885672003736Introducer Set with Hemostatic Valve, 5F
10885672003729Introducer Set with Hemostatic Valve, 4F
10885672002197Introducer Set with Hemostatic Valve, 6F
10885672002180Introducer Set with Hemostatic Valve, 5F
10885672002173Introducer Set with Hemostatic Valve, 4F
10885672002166Introducer Set with Hemostatic Valve, 6F
10885672002159Introducer Set with Hemostatic Valve, 5F
10885672002142Introducer Set with Hemostatic Valve, 4F
10885672000636Introducer Set with Hemostatic Valve, 6F
10885672000629Introducer Set with Hemostatic Valve, 5F
10885672000612Introducer Set with Hemostatic Valve, 4F
10885672000599Introducer Set with Hemostatic Valve, 6F
10885672000582Introducer Set with Hemostatic Valve, 5F
10885672000575Introducer Set with Hemostatic Valve, 4F

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