FDA.report

Alpine Biomed

Primary DI
05704736001045
Brand
Alpine Biomed
Company
Alpine Biomed ApS
Model
9013P0622
Device description
HUSH™ Alligator Clip Electrode with 32' leads - Black
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05704736001045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05704736001045057047360010455704736001045

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

Regulatory Flags

DUNS number
311231554
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05704736008747Alpine BioMed9031A0701012016-08-23
05704736010283Alpine BioMed9031A07012016-08-23
05704736000567Alpine Biomed 9013S03022016-10-13
05704736000581Alpine Biomed9013S03322016-10-13
05704736000598Alpine Biomed 9013S03522016-10-13
05704736000611Alpine Biomed 9013S04022016-10-13
05704736001793Alpine BioMed9031A0065AA2016-08-23
05704736001809Alpine BioMed9031A0065HA2016-08-23
05704736001823Alpine BioMed9031A0065022016-08-23
05704736001830Alpine BioMed9031A0065032016-08-23
05704736001847Alpine BioMed9031A0065042016-08-23
05704736001854Alpine BioMed9031A0065052016-08-23
05704736001861Alpine BioMed9031A0065062016-08-23
05704736002035Alpine Biomed9013R02132016-10-13
05704736002158Alpine Biomed 9013R03132016-10-13
05704736002288Alpine BioMed9031C05032016-08-23
05704736002295Alpine Biomed 9031C05122016-10-13
05704736002301Alpine Biomed9031C05232016-10-13
05704736002318Alpine Biomed9031C05532016-10-13
05704736002332Alpine Biomed9031E01262016-10-13

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