FDA.reportPublic FDA data

FREMAP Electrode

Primary DI
00841823108487
Brand
FREMAP Electrode
Company
Ad-Tech Medical Instrument Corporation
Model
DCNE-01-05X
Catalog number
DCNE-01-05X
Published
2016-10-03
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
ETNSTIMULATOR, NERVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152769000FREMAP ELECTRODEAd-Tech Medical Instrument Corporation2016-05-06ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90841823108480PackageGS15In Commercial Distribution
00841823108487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
9084182310848090841823108480
00841823108487008418231084878418231084870841823108487

GMDN Terms#

Term, Definition table
TermDefinition
Cortical electrodeA sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Contacts#

Phone, Email table
PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags#

DUNS number
174813410
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841823111029Depth ElectrodeMM16H-SP05X-0D5MM16H-SP05X-0D52026-06-03
00841823108814Anchor Bolt Kit, LSB StyleLSBK1-AX-05LSBK1-AX-052026-04-08
00841823108821Anchor Bolt Kit, LSB StyleLSBK1-BX-05LSBK1-BX-052023-08-28
00841823108838Anchor Bolt Kit, LSB StyleLSBK1-CX-04LSBK1-CX-042023-08-28
00841823108845Anchor Bolt Kit, LSB StyleLSBK1-CX-05LSBK1-CX-052023-08-28
00841823108852Anchor Bolt Kit, LSB StyleLSBK2-AX-04LSBK2-AX-042023-08-28
00841823108869Anchor Bolt Kit, LSB StyleLSBK2-BX-04LSBK2-BX-042023-08-28
00841823109521Anchor Bolt Kit, LSB StyleLSBK1-CX-06LSBK1-CX-062023-08-28
00841823109538Anchor Bolt Kit, LSB StyleLSBK1-BX-06LSBK1-BX-062023-08-28
00841823109545Anchor Bolt Kit, LSB StyleLSBK1-AX-06LSBK1-AX-062023-08-28
00841823101228Subdural ElectrodeDG20A-SP07X-UPBDG20A-SP07X-UPB2016-09-23
00841823101235Subdural ElectrodeDG20A-SP10X-G00DG20A-SP10X-G002016-09-23
00841823101242Subdural ElectrodeDG20A-SP10X-GE2DG20A-SP10X-GE22016-09-23
00841823101259Subdural ElectrodeDG20A-SP10X-T00DG20A-SP10X-T002016-09-23
00841823101266Subdural ElectrodeDG20A-SP10X-U00DG20A-SP10X-U002016-09-23
00841823101273Subdural ElectrodeDG20A-SP10X-UE2DG20A-SP10X-UE22016-09-23
00841823101280Subdural ElectrodeDG24A-SP10X-000DG24A-SP10X-0002016-09-23
00841823101297Subdural ElectrodeDG24A-SP10X-G00DG24A-SP10X-G002016-09-23
00841823101303Subdural ElectrodeDG32A-SP10X-U00DG32A-SP10X-U002016-09-23
00841823101310Subdural ElectrodeDG32A-SP10X-V00DG32A-SP10X-V002016-09-23

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