Peel-away introducer set DYNJINTROPL8

GUDID 40888277000552

Peel-away introducer set, 8F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID40888277000552
NIH Device Record Keyc2102956-8461-4bbf-be9f-98dfa71474ab
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeel-away introducer set
Version Model NumberDYNJINTROPL8
Catalog NumberDYNJINTROPL8
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 Datefalse
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

Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
Device Size Text, specify0
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter2.7 Millimeter
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Lumen/Inner Diameter2.7 Millimeter

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
GS100888277000554 [Unit of Use]
GS140888277000552 [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 Date2017-11-30

On-Brand Devices [Peel-away introducer set]

40888277000569Peel-away introducer set, 9F
40888277000552Peel-away introducer set, 8F
40888277000545Peel-away introducer set, 7F
40888277000538Peel-away introducer set, 6F
40888277000453Peel-away introducer set, 12F
40888277000446Peel-away introducer set, 11F
40888277000439Peel-away introducer set, 10F
40888277000316Peel-away introducer set, 9.5F
40888277000309Peel-away introducer set, 9F
40888277000293Peel-away introducer set, 8.5F
40888277000286Peel-away introducer set, 8F
40888277000279Peel-away introducer set, 7.5F
40888277000262Peel-away introducer set, 7F
40888277000255Peel-away introducer set, 6F
40888277000248Peel-away introducer set, 12.5F
40888277000231Peel-away introducer set, 12F
40888277000224Peel-away introducer set, 11.5F
40888277000217Peel-away introducer set, 11F
40888277000057Peel-away introducer set, 10.5F
40888277000033Peel-away introducer set, 10F

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