GUDID 00802526491801

Lead Cap Kit

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead cap kit
Primary Device ID00802526491801
NIH Device Record Key7e19d5fc-2987-4360-9460-02d173c8da73
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6623
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526491801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

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 Date2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729011378 - Lubriglide2024-12-23 Coated Guidewire
08714729011392 - Lubriglide2024-12-23 Coated Guidewire
08714729012580 - Lubriglide2024-12-23 Coated Guidewire
08714729012603 - Lubriglide2024-12-23 Coated Guidewire
08714729012610 - Lubriglide2024-12-23 Coated Guidewire
08714729056645 - Lubriglide2024-12-23 Coated Guidewire
08714729057062 - Lubriglide2024-12-23 Coated Guidewire
08714729080602 - MaxForce TTS2024-12-23 High Performance Balloon Dilatation Catheter

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.