SafeSheath® Ultra SUL8

GUDID 30891492002532

Hemostatic Tear-away Introducer System with Infusion Side Port, 8F

Oscor Inc.

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Primary Device ID30891492002532
NIH Device Record Keyf3623786-509c-4725-b495-8604c9fb61d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeSheath® Ultra
Version Model NumberSUL8
Catalog NumberSUL8
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
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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Needle Gauge18 Gauge
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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

Device Identifiers

Device Issuing AgencyDevice ID
GS100891492002531 [Unit of Use]
GS130891492002532 [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 Date2017-11-27

On-Brand Devices [SafeSheath® Ultra]

30891492002600Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
30891492002594Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
30891492002587Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
30891492002570Hemostatic Tear-away Introducer System with Infusion Side Port, 12.5F
30891492002563Hemostatic Tear-away Introducer System with Infusion Side Port, 12F
30891492002556Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
30891492002549Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
30891492002532Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
30891492002525Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
30891492002518Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
30891492002501Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
30891492002495Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
30891492002488Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F
30891492002471Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
30891492002464Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
30891492002457Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
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