FDA.report

Ear Tip ET-S03 Pack/250 pcs.

Primary DI
04260223142000
Brand
Ear Tip ET-S03 Pack/250 pcs.
Company
PATH medical GmbH
Model
100031-250
Published
2016-08-31
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
true

Related Records

Product Codes

CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications

CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260223142000PrimaryGS10
04260223140655Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260223142000042602231420004260223142000
04260223140655042602231406554260223140655

GMDN Terms

TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Sterilization Methods

Method

Regulatory Flags

DUNS number
551540334
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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