FDA.reportPublic FDA data

KING Disposable Subdermal Corkscrew Needle Electrode

Primary DI
00663427000031
Brand
KING Disposable Subdermal Corkscrew Needle Electrode
Company
Kego Corporation
Model
KM-702325
Device description
"KING Disposable Subdermal Corkscrew Needle Electrode Qty 24 2.5 m (100"") .6mm (23g.)"
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
00663427000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00663427000031006634270000316634270000310663427000031

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
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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