Adelante S ASU01013B5

GUDID 10885672104563

Peel-Away Introducer with Hemostatic Valve and Side Port, 10F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID10885672104563
NIH Device Record Key4fb00229-a6de-4402-ae20-18e4547efa04
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdelante S
Version Model NumberASU01013B5
Catalog NumberASU01013B5
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

Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter3.3 Millimeter
Needle Gauge18 Gauge

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
GS100885672104566 [Unit of Use]
GS110885672104563 [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 S]

10885672104686Peel-Away Introducer with Hemostatic Valve and Side Port, 11F
10885672104679Peel-Away Introducer with Hemostatic Valve and Side Port, 10F
10885672104662Peel-Away Introducer with Hemostatic Valve and Side Port, 9F
10885672104655Peel-Away Introducer with Hemostatic Valve and Side Port, 8F
10885672104648Peel-Away Introducer with Hemostatic Valve and Side Port, 7F
10885672104631Peel-Away Introducer with Hemostatic Valve and Side Port, 6F
10885672104624Peel-Away Introducer with Hemostatic Valve and Side Port, 7.5F
10885672104617Peel-Away Introducer with Hemostatic Valve and Side Port, 5F
10885672104600Peel-Away Introducer with Hemostatic Valve and Side Port, 12.5F
10885672104594Peel-Away Introducer with Hemostatic Valve and Side Port, 12F
10885672104587Peel-Away Introducer with Hemostatic Valve and Side Port, 11F
10885672104570Peel-Away Introducer with Hemostatic Valve and Side Port, 10.5F
10885672104563Peel-Away Introducer with Hemostatic Valve and Side Port, 10F
10885672104556Peel-Away Introducer with Hemostatic Valve and Side Port, 9.5F
10885672104549Peel-Away Introducer with Hemostatic Valve and Side Port, 9F
10885672104532Peel-Away Introducer with Hemostatic Valve and Side Port, 8.5F
10885672104525Peel-Away Introducer with Hemostatic Valve and Side Port, 8F
10885672104518Peel-Away Introducer with Hemostatic Valve and Side Port, 7F
10885672104501Peel-Away Introducer with Hemostatic Valve and Side Port, 6F

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