FDA.report

MediMax Tech

Primary DI
20817325020101
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
BC7523 Needle Electrodes
Device description
BC7523 Needle Electrodes - Concentric Needle, Non-Wired, 75mm Length, 0.65mm(23G) Diameter.
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXZElectrode, Needle

Product Code Classifications

CodeDeviceSpecialtyClass
GXZElectrode, NeedleNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817325020104PackageGS125In Commercial Distribution
20817325020101PackageGS18In Commercial Distribution
00817325020107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502010410817325020104
2081732502010120817325020101
00817325020107008173250201078173250201070817325020107

GMDN Terms

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

Contacts

PhoneEmail
855-633-4629malorie.c@medimaxtech.com

Regulatory Flags

DUNS number
927071162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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