PSW 411917

GUDID 04035479150211

BIOTRONIK SE & Co. KG

Cardiac pulse generator programmer
Primary Device ID04035479150211
NIH Device Record Keya50d4daf-d1f1-40b6-baf6-40c130d2501c
Commercial Distribution Discontinuation2020-10-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePSW
Version Model Number1503.U
Catalog Number411917
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479150211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-20
Device Publish Date2016-01-04

On-Brand Devices [PSW]

040354791663971904.U
040354791576921703.U
040354791576781702.U
040354791541651506.U/1
040354791527651507.U
040354791502041502.U
040354791492601501.U
040354791471431403.U
040354791406701304.U
040354791403801307.U
040354791518431506.U
040354791502111503.U
040354791747982100.U
040354791608381801.U
040354791577081704.U
040354791620471802.U
040354791644231901.U
040354791644161804.U
040354791780242201.U/1
040354791815432301.U
040354791796322204.U
040354791842922303.U
040354791860122401.U
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