FDA.report

Senti Set 1

Primary DI
04260223143151
Brand
Senti Set 1
Company
PATH medical GmbH
Model
100330
Device description
Senti Audiometry (Class 4 Advanced) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 4A AN100653 6. Headphone HDA-280 AN100117 7. Power supply AN100083 8. USB data cable AN100089
Published
2018-05-14
Public version status
Update
Distribution status
Not 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
EWOAudiometer

Product Code Classifications

CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260223143151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260223143151042602231431514260223143151

GMDN Terms

TermDefinition
Pure-tone audiometerAn electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.

Sterilization Methods

Method

Regulatory Flags

DUNS number
551540334
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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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05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245110Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245127Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
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