FDA.reportPublic FDA data

KING Disposable Subdermal Corkscrew Needle Electrode

Primary DI
00663427000017
Brand
KING Disposable Subdermal Corkscrew Needle Electrode
Company
Kego Corporation
Model
KM-702310
Device description
"KING Disposable Subdermal Corkscrew Needle Electrode Qty 24 1.0 m (40"") .6 mm (23 g.)"
Published
2017-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXZElectrode, Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072276000SUBDERMAL NEEDLE ELECTRODESXian Friendship Electronics Co., Ltd.2008-05-16GXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00663427000017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00663427000017006634270000176634270000170663427000017

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
208120423
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00663427000482KINGKM-S022KM-S0222023-11-09
00663427000543KINGKM-S023KM-S0232023-11-09
00663427000574KINGKM-S025KM-S0252023-11-09
00663427000581KINGKM-S026KM-S0262023-11-09
00663427000499KINGKM-S020KM-S0202023-11-07
00663427000505KINGKM-S021KM-S0212023-11-07
00663427000529KINGKM-S011KM-S0112023-11-07
00663427000536KINGKM-S008KM-S0082023-11-07
00663427001113KINGKM-1320/EKM-13202023-11-07
00663427000598KING Shielded Acq. CableKM-P050580RG 2021-12-08
00663427000604KING Shielded Acq. CableKM-P050580R 2021-12-08
00663427000123KING Connector KM-PA0302RBG2019-06-04
00663427000130KING Electrode Lead CableKM-PA01005B2019-06-04
00663427000147KING Electrode Lead CableKM-PA01005G2019-06-04
00663427000154KING Electrode Lead CableKM-PA01005R2019-06-04
00663427000161KING Electrode Lead CableKM-PA01036G2019-06-04
00663427000178KING Electrode Lead CableKM-PA01048B2019-06-04
00663427000185KING Electrode Lead CableKM-PA01048G2019-06-04
00663427000192KING Electrode Lead CableKM-PA01048R2019-06-04
00663427000208KING Electrode Lead CableKM-PA01060B2019-06-04

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