Adelante Sigma

GUDID 10885672001770

Introducer Set with Hemostatic Valve, 4F

Oscor Inc.

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 ID10885672001770
NIH Device Record Key92189356-94eb-4ad5-97b1-484df5cbd161
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdelante Sigma
Version Model NumberASG0402335
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

Device Size Text, specify0
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Lumen/Inner Diameter1.4 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter1.4 Millimeter
Device Size Text, specify0
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
GS100885672001773 [Unit of Use]
GS110885672001770 [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 Sigma]

00885672008772Introducer Set with Hemostatic Valve, 6F
20885672101446Introducer Set with Hemostatic Valve, 12F
20885672101439Introducer Set with Hemostatic Valve, 11F
20885672101422Introducer Set with Hemostatic Valve, 10F
20885672101415Introducer Set with Hemostatic Valve, 9F
20885672101408Introducer Set with Hemostatic Valve, 8F
20885672101392Introducer Set with Hemostatic Valve, 7F
20885672101385Introducer Set with Hemostatic Valve, 6F
20885672101378Introducer Set with Hemostatic Valve, 5F
20885672101361Introducer Set with Hemostatic Valve, 4F
20885672101354Introducer Set with Hemostatic Valve, 12F
20885672101347Introducer Set with Hemostatic Valve, 11F
20885672101330Introducer Set with Hemostatic Valve, 10F
20885672101323Introducer Set with Hemostatic Valve, 9F
20885672101316Introducer Set with Hemostatic Valve, 8F
20885672101309Introducer Set with Hemostatic Valve, 7F
20885672101293Introducer Set with Hemostatic Valve, 6F
20885672101286Introducer Set with Hemostatic Valve, 5F
20885672101279Introducer Set with Hemostatic Valve, 4F
10885672101050Hemostatic Valve Introducer, 12F
10885672101036Hemostatic Valve Introducer, 11F
10885672101012Hemostatic Valve Introducer, 10F
10885672100992Hemostatic Valve Introducer, 9F
10885672100978Hemostatic Valve Introducer, 8F
10885672100954Hemostatic Valve Introducer, 7F
10885672100923Hemostatic Valve Introducer, 4F
10836559009464Hemostatic Valve Introducer, 12F
10836559009457Hemostatic Valve Introducer, 11F
10836559009440Hemostatic Valve Introducer, 10F
10836559009433Hemostatic Valve Introducer, 9F
10836559007415Hemostatic Valve Introducer, 8F
10836559007408Hemostatic Valve Introducer, 7F
10836559007378Hemostatic Valve Introducer, 4F
10885672100947Introducer Set with Hemostatic Valve, 6F
10885672100930Introducer Set with Hemostatic Valve, 5F
10885672009233Hemostatic Valve Introducer, 6F
10885672009226Hemostatic Valve Introducer, 5F
10885672009219Hemostatic Valve Introducer, 6F
10885672009202Hemostatic Valve Introducer, 5F
10885672009134Hemostatic Valve Introducer, 12F
10885672009127Hemostatic Valve Introducer, 11F
10885672009110Hemostatic Valve Introducer, 10F
10885672009103Hemostatic Valve Introducer, 9F
10885672009097Hemostatic Valve Introducer, 8F
10885672009080Hemostatic Valve Introducer, 7F
10885672009073Hemostatic Valve Introducer, 6F
10885672009066Hemostatic Valve Introducer, 5F
10885672009059Hemostatic Valve Introducer, 4F
10885672009042Hemostatic Valve Introducer, 12F
10885672009035Hemostatic Valve Introducer, 11F

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