Transvalvular Insertion Tool (TVI) 667612-100

GUDID 00885672010058

Transvalvular Insertion Tool, 11F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID00885672010058
NIH Device Record Keye6f311fc-e445-4d45-b7ed-e189cb1c00c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransvalvular Insertion Tool (TVI)
Version Model Number667612-100
Catalog Number667612-100
Company DUNS101835833
Company NameOscor Inc.
Device Count25
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
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter
Length9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885672010058 [Unit of Use]
GS130885672010059 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [Transvalvular Insertion Tool (TVI)]

20802526552704Transvalvular Insertion Tool, 11F
00885672010058Transvalvular Insertion Tool, 11F

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