NATUS NEUROLOGY

GUDID 00382830032582

ELC/EPIDURAL SPINAL W/DIN 1PER

NATUS NEUROLOGY INCORPORATED

Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use
Primary Device ID00382830032582
NIH Device Record Keyc41d7bb9-3775-4c61-8498-acd6bb23a18a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNATUS NEUROLOGY
Version Model NumberCEDL-1PDINX-000
Company DUNS874257488
Company NameNATUS NEUROLOGY INCORPORATED
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830032582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [NATUS NEUROLOGY]

00382830039598ELC/EEG SIL 6MM 1M, 12PK, DIN
00382830039581ELC/EEG SIL 6MM 1.5M, 12PK, DIN
00382830039574ELC/EEG GLD 6MM 1M, 12 PK, DIN
00382830039567ELC/EEG GLD 6MM 1.5M, 12PK, DIN
00382830039550ELC/ADAPTOR 2MM/1.5MM SOCKET
00382830038638ALLIGATR CLP 1.25M LD 1 SET/PK
00382830037952ELC/DIG RING REUSABLE/36" LEAD
00382830037679PROBE 2MHZ MONITORING SONARA
00382830037181ASSY/TCD REMOTE CONTROL ENG
00382830037112NicoletOne V44 Amplifier
00382830037068ASSY/TCD REMOTE CONTROL GER
00382830037051ASSY/TCD REMOTE CONTROL RUS
00382830037044EDX Analog Output Box and Cable
00382830037037Stimulus Switching Pod SP1
00382830037020Stimulus Switching Pod SP2
0038283003701310-20 Headbox for Wireless EEG Amplifier
0038283003700610-20 Headbox kit for Wireless EEG Amplifier
00382830036993ASSY/EEG V44 AMP + DC OFFSET
00382830036979ELECTRODE/SURFACE SEPERATE PR
00382830036962ELECTRODE/SURFACE TWISTED PAIR
00382830036955ELC/DIG RING REUSABLE/18" LEAD
00382830036887VQ AMP ISI-2
00382830036863VQ AMP ISI-4
00382830036757SONARA-TEK LAPTOP
00382830036641NIC CSC64 SSU AMP W/CBL HOLDER
00382830035927LRU/VS EA-4 AMPLIFIER SHLD/HSG-FIXED
00382830035910ISOBOX 850VA SOTB FW 120V
00382830035903LRU VikingQuest Base Unit F Part
00382830035842LRU/SYNERGY HP TOWER USA-FIXED
00382830034654Nicolet LED Goggles
00382830034647Nicolet S403 Stimulus Probe
00382830034630Nicolet Reflex Hammer
00382830034623VikingQuest Auditory Stimulator
00382830034579Endeavor CR Desktop PC
00382830034500Viking Control Panel - German
00382830034494Viking Control Panel - French
00382830034456ELC/ERG-JET CONTACT LENS
00382830034449TIP 3.5MM INFANT EARTIP (10PR)
00382830034432TIP 4MM INFANT EARTIPS (10PR)
00382830034425TIP 5MM INFANT EARTIPS (10PR)
00382830034418ELC/DISP CENTR SNAP RND (10PK)
00382830033893Viking EDX Control Panel
00382830033879Synergy EDX Control Panel
00382830033848EDX Desktop PC
00382830033831EDX Desktop PC - Demo Sale
00382830033824EDX Laptop PC
00382830033817EDX Laptop PC - Demo Sale
00382830033534UltraPro S100 Laptop PC
0038283003341124" SHIELDED LEADED WIRE FOR DISPOSABLE MONOPOLAR NEEDLES ELECTRODES
00382830033381ELC/ALLERGAN NEEDLES 4 PCK

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