TB TBRHK05110SSG

GUDID 00885672004385

Temporary Pacing Lead Convenience Kit, 5F, Right Heart Curve Shrouded

Oscor Inc.

Atrial cardioversion system catheter
Primary Device ID00885672004385
NIH Device Record Keyc8e5aa69-e1c0-43ed-99cd-5eb53e8d6b7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTB
Version Model NumberTBRHK05110SSG
Catalog NumberTBRHK05110SSG
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Dimensions

Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 Millimeter
Length110 Centimeter
Outer Diameter1.7 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672004385 [Primary]

FDA Product Code

LDFELECTRODE, PACEMAKER, TEMPORARY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-27

On-Brand Devices [TB]

00885672103682Temporary Pacing Lead Convenience Kit, 6F, Right Heart Curve Unshrouded
00885672103675Temporary Pacing Lead Convenience Kit, 6F, Right Heart Curve Shrouded
00885672007034Temporary Pacing Lead Convenience Kit, 4F, J Curve Unshrouded
00885672007027Temporary Pacing Lead Convenience Kit, 4F, 60° Curve Unshrouded
00885672004392Temporary Pacing Lead Convenience Kit, 5F, Right Heart Curve Unshrouded
00885672004385Temporary Pacing Lead Convenience Kit, 5F, Right Heart Curve Shrouded
00885672004378Temporary Pacing Lead Convenience Kit, 4F, Right Heart Curve Unshrouded
00885672004361Temporary Pacing Lead Convenience Kit, 4F, Right Heart Curve Shrouded
00885672004354Temporary Pacing Lead Convenience Kit, 6F, 60° Curve Unshrouded
00885672004347Temporary Pacing Lead Convenience Kit, 6F, 60° Curve Shrouded
00836559009924020024
00836559009917020023
00836559009900020022
00836559009894020021
00836559009887020020
00836559009870020019
00836559009863020018
00836559009856020017
00836559009849020016
00836559009832020015
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00836559009740020006
00836559009733020005
00836559009726020004
00836559009719020003
00836559009702020002
00836559009696020001
00836559009078TBK06110USG
00836559009061TBK06110SSG
00836559009054TBK05110USG
00836559009047TBK05110SSG
00836559009030TBK04110USG
00836559009023TBK04110SSG

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