Occlutech® Steerable Guiding Sheath 51GS012

GUDID 07350048971149

Steerable Guiding Sheath, 12F

Oscor Inc.

Vascular guide-catheter, single-use
Primary Device ID07350048971149
NIH Device Record Keyc52b4f71-3cf8-4a37-9f04-a4d1e91588ba
Commercial Distribution Discontinuation2019-10-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOcclutech® Steerable Guiding Sheath
Version Model Number51GS012
Catalog Number51GS012
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

Device Dimensions

Device Size Text, specify0
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Lumen/Inner Diameter4.2 Millimeter
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Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 Millimeter
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter4.2 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
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350048971149 [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 Date2019-10-11
Device Publish Date2017-11-21

On-Brand Devices [Occlutech® Steerable Guiding Sheath]

07350048971156Steerable Guiding Sheath, 14F
07350048971149Steerable Guiding Sheath, 12F
00885672009410Steerable Guiding Sheath, 14F
00885672009403Steerable Guiding Sheath, 12F

Trademark Results [Occlutech]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OCCLUTECH
OCCLUTECH
97105233 not registered Live/Pending
BIOMODEX SAS
2021-11-02
OCCLUTECH
OCCLUTECH
86093034 5124620 Live/Registered
Occlutech Holding AG
2013-10-16

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