Model 4625 ACUITY® X4 Connector Tool

GUDID 00802526527456

Connector Tool

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead repair kit
Primary Device ID00802526527456
NIH Device Record Keyb2a6f941-3a21-442d-8329-ea00f58f2351
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 4625 ACUITY® X4 Connector Tool
Version Model Number4625
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 Identifiers

Device Issuing AgencyDevice ID
GS100802526527456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

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 Date2015-02-09

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