DiRex™ Steerable Sheath M004DS20S0

GUDID 08714729858935

Steerable sheath, 8.5F

Oscor Inc.

Vascular guide-catheter, single-use
Primary Device ID08714729858935
NIH Device Record Keya3f8ec14-6052-4ffc-bb1b-07d823a93ecc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiRex™ Steerable Sheath
Version Model NumberM004DS20S0
Catalog NumberM004DS20S0
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

Device Dimensions

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Lumen/Inner Diameter2.8 Millimeter
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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

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729858935 [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 Number6
Public Version Date2020-07-23
Device Publish Date2017-11-19

On-Brand Devices [DiRex™ Steerable Sheath]

00885672009373Steerable sheath, 12F
00885672009366Steerable sheath, 12F
00885672009359Steerable sheath, 10F
00885672009342Steerable sheath, 10F
00885672009335Steerable sheath, 8.5F
00885672009328Steerable sheath, 8.5F
00885672009311Steerable sheath, 8.5F
00885672009304Steerable sheath, 8.5F
00885672009298Steerable sheath, 8.5F
00885672009281Steerable sheath, 8.5F
08714729858997Steerable sheath, 12F
08714729858980Steerable sheath, 12F
08714729858973Steerable sheath, 10F
08714729858966Steerable sheath, 10F
08714729858959Steerable sheath, 8.5F
08714729858942Steerable sheath, 8.5F
08714729858935Steerable sheath, 8.5F
08714729858928Steerable sheath, 8.5F
08714729858911Steerable sheath, 8.5F
08714729858904Steerable sheath, 8.5F

Trademark Results [DiRex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIREX
DIREX
85607659 4355242 Live/Registered
BOSTON SCIENTIFIC SCIMED, INC.
2012-04-25
DIREX
DIREX
79362192 not registered Live/Pending
Wacker Neuson Produktion GmbH & Co. KG
2022-12-22
DIREX
DIREX
78586104 not registered Dead/Abandoned
Bradley W. Miller
2005-03-13
DIREX
DIREX
78192609 not registered Dead/Abandoned
DIREX INC.
2002-12-09
DIREX
DIREX
77965070 not registered Dead/Abandoned
Smart Business Technology
2010-03-22
DIREX
DIREX
77115689 not registered Dead/Abandoned
Quantum Medical Imaging, LLC
2007-02-25
DIREX
DIREX
75320094 not registered Dead/Abandoned
Truvativ International Co., Ltd.
1997-07-07
DIREX
DIREX
74148672 1676536 Live/Registered
ADAMA AGAN LTD.
1991-03-18
DIREX
DIREX
73765329 not registered Dead/Abandoned
NIXDORF COMPUTER AG
1988-11-18
DIREX
DIREX
73477708 1368710 Dead/Cancelled
INTRAK, INC.
1984-04-27
DIREX
DIREX
72275090 0865700 Dead/Expired
VICTORY DIAMOND TOOL COMPANY
1967-06-29
DIREX
DIREX
71489864 0421563 Dead/Expired
GRANT PHOTO PRODUCTS, INC.
1945-10-12

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