NCP® Programming Wand Model 201

GUDID 05425025750160

Programming Wand

LIVANOVA USA, INC.

Vagus nerve electrical stimulation system programmer
Primary Device ID05425025750160
NIH Device Record Key901efd7b-0e72-4e86-84bf-3a12ab41aab6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNCP® Programming Wand Model 201
Version Model Number201
Company DUNS194568978
Company NameLIVANOVA USA, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (866) 882-8804
EmailClinicalTechnicalServices@cybe

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105425025750160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUZStimulator, Autonomic Nerve, Implanted (Depression)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-17

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