Destino Steerable Guiding Sheath DS107150

GUDID 00885672000455

Steerable Guiding Sheath, 10F

Oscor Inc.

Vascular guide-catheter, single-use
Primary Device ID00885672000455
NIH Device Record Key283187a9-5038-49e8-a824-d8a7b33aa0bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDestino Steerable Guiding Sheath
Version Model NumberDS107150
Catalog NumberDS107150
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
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

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Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
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Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter4.7 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter3.6 Millimeter
Device Size Text, specify0
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
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
GS100885672000455 [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 Number5
Public Version Date2019-01-23
Device Publish Date2017-11-27

On-Brand Devices [Destino Steerable Guiding Sheath]

00885672004538Steerable Guiding Sheath, 12F
00885672001254Steerable Guiding Sheath, 12F
00885672001247Steerable Guiding Sheath, 12F
00885672001230Steerable Guiding Sheath, 12F
00885672001223Steerable Guiding Sheath, 12F
00885672001216Steerable Guiding Sheath, 12F
00885672001209Steerable Guiding Sheath, 12F
00885672001193Steerable Guiding Sheath, 10F
00885672001186Steerable Guiding Sheath, 10F
00885672001179Steerable Guiding Sheath, 10F
00885672001162Steerable Guiding Sheath, 10F
00885672001155Steerable Guiding Sheath, 10F
00885672001148Steerable Guiding Sheath, 10F
00885672001131Steerable Guiding Sheath, 8.5F
00885672001124Steerable Guiding Sheath, 8.5F
00885672001117Steerable Guiding Sheath, 8.5F
00885672001100Steerable Guiding Sheath, 8.5F
00885672001094Steerable Guiding Sheath, 8.5F
00885672001087Steerable Guiding Sheath, 8.5F
00885672001070Steerable Guiding Sheath, 8.5F
00885672001063Steerable Guiding Sheath, 12F
00885672001056Steerable Guiding Sheath, 12F
00885672001049Steerable Guiding Sheath, 12F
00885672001032Steerable Guiding Sheath, 12F
00885672001025Steerable Guiding Sheath, 12F
00885672001018Steerable Guiding Sheath, 12F
00885672001001Steerable Guiding Sheath, 10F
00885672000998Steerable Guiding Sheath, 10F
00885672000981Steerable Guiding Sheath, 10F
00885672000974Steerable Guiding Sheath, 10F
00885672000967Steerable Guiding Sheath, 10F
00885672000950Steerable Guiding Sheath, 10F
00885672000943Steerable Guiding Sheath, 8.5F
00885672000936Steerable Guiding Sheath, 8.5F
00885672000929Steerable Guiding Sheath, 8.5F
00885672000912Steerable Guiding Sheath, 8.5F
00885672000905Steerable Guiding Sheath, 8.5F
00885672000899Steerable Guiding Sheath, 8.5F
00885672000882Steerable Guiding Sheath, 8.5F
00885672000875Steerable Guiding Sheath, 8.5F
00885672000868Steerable Guiding Sheath, 8.5F
00885672000851Steerable Guiding Sheath, 12F
00885672000844Steerable Guiding Sheath, 12F
00885672000837Steerable Guiding Sheath, 12F
00885672000820Steerable Guiding Sheath, 12F
00885672000813Steerable Guiding Sheath, 12F
00885672000806Steerable Guiding Sheath, 12F
00885672000790Steerable Guiding Sheath, 10F
00885672000783Steerable Guiding Sheath, 10F
00885672000776Steerable Guiding Sheath, 10F

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