LS14B20

GUDID 70885672103568

Oscor Inc.

Pacing/defibrillation lead suture sleeve
Primary Device ID70885672103568
NIH Device Record Key7173fdeb-66e7-4bfb-8efe-736956a54488
Commercial Distribution StatusIn Commercial Distribution
Brand NameLS14B20
Version Model NumberLS14B20
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS170885672103568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTBPermanent Pacemaker Electrode

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 Date2015-10-16

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