FDA.reportPublic FDA data

NIM-Neuro®

Primary DI
00613994499646
Brand
NIM-Neuro®
Company
MEDTRONIC XOMED, INC.
Model
8253401
Device description
MAINFRAME 8253401 NIM NEURO 3.0
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083124000NIM 3.0Medtronic Xomed, Inc.2009-02-27GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994499646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994499646006139944996466139944996460613994499646

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system, line-poweredAn assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000032746Neuray®80040052019-03-17
00763000032784Neuray®80040002019-03-17
00763000032791Neuray®80040012019-03-17
00763000032807Neuray®80040022019-03-17
00763000032814Neuray®80040032019-03-17
00763000032821Neuray®80040042019-03-17
00763000032838Neuray®80040062019-03-17
00763000032845Neuray®80040072019-03-23
00763000032869Neuray®80040092019-03-17
00763000843908NIM VitalNIM4CM012026-08-22
00763000843915NIM VitalNIM4CPB12026-08-22
00199150037407NIM™8225825X2026-03-29
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810161901555EARP NERVE CUFF ELECTRODE, 4MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
00810161901579EARP NERVE CUFF ELECTRODE, 6MM (Sterile)RETROPSOAS TECHNOLOGIES, LLCETN2026-10-15
04250307604388N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604388N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHETN2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHGWF2026-10-01
00763000843908NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843908NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.ETN2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
10840113234728BovieASPEN SURGICAL PRODUCTS, INC.ETN2026-08-17
00887517127693MaXcessNuvasive, Inc.ETN2026-07-27
00199874344553MEGA-TMSSoterix Medical TechnologiesGWF2026-07-10
00763000821777NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821784NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821791NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821807NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
00763000821814NIM EssenceMEDTRONIC XOMED, INC.ETN2026-06-07
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
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00199150037407NIM™MEDTRONIC XOMED, INC.ETN2026-03-29