Adelante Peel-Away Introducer Set AP07016

GUDID 00836559006732

Peel-Away Introducer Set, 7F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID00836559006732
NIH Device Record Keyfe50ccd9-fa97-4987-b236-1a8656df7f97
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdelante Peel-Away Introducer Set
Version Model NumberAP07016
Catalog NumberAP07016
Company DUNS101835833
Company NameOscor Inc.
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 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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge18 Gauge
Lumen/Inner Diameter2.3 Millimeter
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
GS100836559006732 [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 Date2017-11-15

On-Brand Devices [Adelante Peel-Away Introducer Set]

20885672103556Peel-Away Introducer Set, 9F
20885672101262Peel-Away Introducer Set, 12F
20885672101255Peel-Away Introducer Set, 11F
20885672101248Peel-Away Introducer Set, 10F
20885672101231Peel-Away Introducer Set, 9F
20885672101224Peel-Away Introducer Set, 8F
20885672101217Peel-Away Introducer Set, 7F
20885672101200Peel-Away Introducer Set, 12.5F
20885672101194Peel-Away Introducer Set, 12F
20885672101187Peel-Away Introducer Set, 11.5F
20885672101170Peel-Away Introducer Set, 11F
20885672101163Peel-Away Introducer Set, 10.5F
20885672101156Peel-Away Introducer Set, 10F
20885672101149Peel-Away Introducer Set, 9.5F
20885672101132Peel-Away Introducer Set, 9F
20885672101125Peel-Away Introducer Set, 8.5F
20885672101118Peel-Away Introducer Set, 8F
20885672101101Peel-Away Introducer Set, 7.5F
20885672101095Peel-Away Introducer Set, 7F
20885672101088Peel-Away Introducer Set, 6F
20885672008820Peel-Away Introducer Set, 6F
20885672002484Peel-Away Introducer Set, 8F
20885672002460Peel-Away Introducer Set, 7F
20885672002453Peel-Away Introducer Set, 6F
20885672002132Peel-Away Introducer Set, 12.5F
20885672002125Peel-Away Introducer Set, 12F
20885672002118Peel-Away Introducer Set, 11.5F
20885672002101Peel-Away Introducer Set, 11F
20885672002095Peel-Away Introducer Set, 10.5F
20885672002088Peel-Away Introducer Set, 10F
20885672002071Peel-Away Introducer Set, 9.5F
20885672002064Peel-Away Introducer Set, 9F
20885672002057Peel-Away Introducer Set, 8.5F
20885672002040Peel-Away Introducer Set, 8F
20885672002033Peel-Away Introducer Set, 7.5F
20885672002026Peel-Away Introducer Set, 7F
20885672000060Peel-Away Introducer Set, 6F
10885672100190Peel-Away Introducer Set, 12F
10885672100183Peel-Away Introducer Set, 11F
10885672100176Peel-Away Introducer Set, 10F
10885672100169Peel-Away Introducer Set, 9F
10885672100152Peel-Away Introducer Set, 8F
10885672100145Peel-Away Introducer Set, 7F
10885672100138Peel-Away Introducer Set, 12.5F
10885672100121Peel-Away Introducer Set, 12F
10885672100114Peel-Away Introducer Set, 11.5F
10885672100107Peel-Away Introducer Set, 11F
10885672100091Peel-Away Introducer Set, 10.5F
10885672100084Peel-Away Introducer Set, 10F
10885672100077Peel-Away Introducer Set, 9.5F

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