STERILE Mapping Probe

GUDID 00852184003090

Synapse Biomedical, Inc.

Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return
Primary Device ID00852184003090
NIH Device Record Key62eb2343-1c43-4d8a-a59d-b68792a39a42
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERILE Mapping Probe
Version Model Number21-0001-99
Company DUNS138432070
Company NameSynapse Biomedical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
GS100852184003090 [Primary]

FDA Product Code

OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-24

Devices Manufactured by Synapse Biomedical, Inc.

00852184003588 - Disposable Electrode Delivery Tool2021-03-24
00852184003618 - 2 Pack, Electrode Delivery Tool Kit2021-03-24
00852184003007 - NeuRx Diaphragm Pacing System2018-03-29
00852184003014 - NeuRx DPS™ System Kit2018-03-29
00852184003021 - NeuRx DPS™ System Kit, ALS CE2018-03-29
00852184003038 - NeuRx DPS™ Surgical Kit, HDE2018-03-29
00852184003045 - NeuRx DPS Patient Kit2018-03-29
00852184003052 - NeuRx DPS™ Patient Kit, 1 EPG2018-03-29

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