SSPC4 Delivery Catheter

GUDID 00810024671847

Catheter and Dilator

CENTERPOINT SYSTEMS LLC

Pacing/defibrillation lead delivery catheter
Primary Device ID00810024671847
NIH Device Record Keyfb923865-731a-4bea-9fdf-bd655710c70e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSSPC4 Delivery Catheter
Version Model Number9184
Company DUNS117126091
Company NameCENTERPOINT SYSTEMS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone877-848-0828
Emailinfo@centerpoint-systems.com

Device Dimensions

Catheter Length40 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100810024671847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-29
Device Publish Date2019-08-21

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