Adelante SafeSheath II AS09023B5

GUDID 10885672002401

Hemostatic Tear-away Introducer System with Infusion Side Port, 9F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID10885672002401
NIH Device Record Keyf5c09978-ce1b-427b-877f-4fd5af4e06e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdelante SafeSheath II
Version Model NumberAS09023B5
Catalog NumberAS09023B5
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 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(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

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

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
GS100885672002404 [Unit of Use]
GS110885672002401 [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 SafeSheath II]

10885672002432Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
10885672002425Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
10885672002418Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
10885672002401Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
10885672002395Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
10885672002388Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
10885672002371Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
10885672002364Hemostatic Tear-away Introducer System with Infusion Side Port, 12.5F
10885672002357Hemostatic Tear-away Introducer System with Infusion Side Port, 12F
10885672002333Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
10885672002326Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
10885672002319Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
10885672002302Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F
10885672002296Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
10885672002289Hemostatic Tear-away Introducer System with Infusion Side Port, 8.5F
10885672002272Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
10885672002258Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
10885672002241Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
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