Lead Adaptor BIS/BIS-40

GUDID 00885672008369

Lead Adaptor

Oscor Inc.

Pacing/defibrillation lead electrical adaptor
Primary Device ID00885672008369
NIH Device Record Key5bc3a797-6eae-46b8-b0a5-ce9d8c0c8d49
Commercial Distribution StatusIn Commercial Distribution
Brand NameLead Adaptor
Version Model NumberBIS/BIS-40
Catalog NumberBIS/BIS-40
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 Numbertrue
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

Device Dimensions

Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672008369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTDpacemaker lead Adaptor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-27

On-Brand Devices [Lead Adaptor]

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00802526497520Lead Adaptor
00802526497513Lead Adaptor
00802526497506Lead Adaptor
00885672008369Lead Adaptor
00885672008352Lead Adaptor
00885672008338Lead Adaptor
00885672008321Lead Adaptor
00885672008284Lead Adaptor
00885672008277Lead Adaptor
00836559005544Lead Adaptor
10885672102453Lead Adaptor
00885672011222Lead Adaptor

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