GUDID 00802526610615

STERILZABLE TELEMETRY WAND

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer
Primary Device ID00802526610615
NIH Device Record Keyc3733906-0265-4d31-bfe7-3b628df26fd5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6395
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526610615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


[00802526610615]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-13
Device Publish Date2020-05-05

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