2 Pack, Electrode Delivery Tool Kit

GUDID 00852184003618

Synapse Biomedical, Inc.

Intramuscular diaphragm/phrenic nerve electrical stimulation system
Primary Device ID00852184003618
NIH Device Record Key93938755-e63e-49ab-ad9d-73d748f5147c
Commercial Distribution StatusIn Commercial Distribution
Brand Name2 Pack, Electrode Delivery Tool Kit
Version Model Number20-0074
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 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852184003618 [Primary]

FDA Product Code

OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-24
Device Publish Date2021-03-16

Devices Manufactured by Synapse Biomedical, Inc.

00852184003588 - Disposable Electrode Delivery Tool2021-03-24
00852184003618 - 2 Pack, Electrode Delivery Tool Kit2021-03-24
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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