FDA.reportPublic FDA data

NA

Primary DI
00613994871497
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
NRE1003
Device description
ELECTRODE NRE1003 SD NEEDLE RECORD ROHS
Published
2016-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXZELECTRODE, NEEDLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050194000AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODESAxon Systems, Inc.2005-04-26GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994871497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994871497006139948714976139948714970613994871497

GMDN Terms#

Term, Definition table
TermDefinition
Subdermal needle electrodeA sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Meter
Length2.5Meter
Length2.7Centimeter
Length5Centimeter
Length13Millimeter
Length22Millimeter
Needle Gauge27Gauge
Width2Centimeter
Width3.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01
20613994394525SLIDE-ON®4444012016-04-23
20613994394747SLIDE-ON®3324012016-04-23
20613994394754SLIDE-ON®3343012016-04-29
20613994657798SLIDE-ON®0351022016-04-29
20613994657811SLIDE-ON®3356012016-04-29
20613994657828SLIDE-ON®4456012016-05-13
00763000032746Neuray®80040052019-03-17

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Primary DI, Brand, Company table
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00816312028614Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-10-08
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10816312028673Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXZ2026-09-21
05707480167579Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
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05707480167630Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
05707480167661Ambu® Neuroline MonopolarAmbu A/SGXZ2026-09-05
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