FDA.reportPublic FDA data

Zipshield 8m

Primary DI
00850011306970
Brand
Zipshield 8m
Company
NEURALYNX, INC.
Model
8m
Catalog number
31-0604-0129
Device description
This product contains a full conductive metal plated cloth inner shield with a durable plastic outer jacket which is easily applied over one or more ATLAS Tether cables providing both noise shielding and cable management.
Published
2024-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110967000ENTERPRISE ELECTROPHYSIOLOGY SYSTEMNeuralynx, Inc.2011-06-30OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011306970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011306970008500113069708500113069700850011306970

GMDN Terms#

Term, Definition table
TermDefinition
Facility radio-frequency shielding materialA radiation protection device consisting of electrically conductive materials used in conjunction with other medical devices in a medical facility to form a barrier against radio-frequency (RF) emissions and interference. This kind of material protects medical devices and/or persons from incident or stray radio-frequency fields. This group of devices includes a wide variety of materials, e.g., copper (Cu) sheeting and copper mesh. Copper sheets and copper mesh are used in walls, floors, ceiling, doors and windows for magnetic resonance imaging rooms to prevent interference with the electronics used to form and receive the radio-frequency imaging pulses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
933200842
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011306314ATLAS Cart - Dual Monitors31-0605-016931-0605-01692026-04-27
00850011306291High Density Tether 7.5m7.5 meter31-0202-00072026-02-19
00850011306307Tether Extension Cable Male-to-Male 3m3 meter31-0613-00312026-02-19
00850011306338ATLAS Stim Headbox - TouchproofTouchproof31-0601-00892025-06-11
00850011306345ATLAS Stim Headbox - High DensityHigh Density31-0601-01322025-06-11
00850011306703ATLAS Stim Headbox Software1.5.136-0301-00062025-06-11
00850011306710Fiber Optic Connector 2m2m31-0204-00012025-06-11
00850011306727Fiber Optic Connector 7m7m31-0204-00022025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofTouchproof31-0204-00042025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNK31-0204-00032025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityHigh Density31-0204-00052025-06-11
00867718000285ATLAS Stim Headbox - NKNK31-0601-00772025-06-11
00850011306512ATLAS Headbox Expansion PanelATLAS HEP31-0607-00142022-11-10
00850011306932ATLAS Workstation MonitorATLAS Workstation Monitor31-0000-00022024-12-18
00850011306949ATLAS WorkstationATLAS Workstation31-0004-00002024-12-18
00850011306956ATLAS Parallel TTL CableATLAS Parallel TTL Cable31-0602-00242024-12-18
00850011306239ATLAS Rackmounted Power IsolatorATLAS Rackmounted Power Isolator31-0607-00152024-12-11
00850011306253Ethernet SwitchEthernet Switch31-0604-01392024-12-11
00850011306963Zipshield 5m5m31-0604-01282024-12-11
00850011306987ATLAS Power Isolator 110VAC110VAC31-0607-00082024-12-11

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