FDA.reportPublic FDA data

Probe Tip 'Adult' PT-A 10pack

Primary DI
04260223142895
Brand
Probe Tip 'Adult' PT-A 10pack
Company
PATH medical GmbH
Model
100013-10
Published
2017-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260223142895PrimaryGS10
04260223140051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260223142895042602231428954260223142895
04260223140051042602231400514260223140051

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
551540334
Device count
10
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260223147326nanoAudio DD45101414-012025-08-05
04260223147333nanoAudio DD65v2101414-022025-08-05
04260223147340nanoAudio Patient Response Button1014202025-08-05
04260223147418Sentiero Screening 3100098-S32025-08-05
04260223147449nanoAudio DD45 Set101470-012025-08-05
04260223147456nanoAudio DD45 Set with Patient Response Button101470-022025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake101470-032025-08-05
04260223147470nanoAudio DD65v2 Set101470-042025-08-05
04260223147487nanoAudio DD65v2 Set with Patient Response Button101470-052025-08-05
04260223147494nanoAudio DD65v2 Set with Patient Response Button and Hughson-Westlake101470-062025-08-05
04260223147630Sentiero Screening3 DPOAE Set100250-SC3-D-LT2025-08-05
04260223147647Sentiero Screening3 TEOAE Set100250-SC3-T-LT2025-08-05
04260223144783Headphone DD-65 v21010442024-09-17
04260223147272QScreen Set101275-AS-ECC2024-09-17
04260223147289QScreen Set101275-AS-EP2024-09-17
04260223147296QScreen Set101275-AS-IP2024-09-17
04260223147302QScreen Set101275-AS-HP2024-09-17
04260223146251QScreen Set101275-T-A-ECC2023-05-19
04260223146299QScreen Set101275-D-A-ECC2023-05-19
04260223146312QScreen Set101275-T-A-IP2023-05-19

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