FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315000072
Brand
GN Otometrics A/S
Company
Gn Otometrics A/S
Model
Specula 3 mm Cerumen
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ERAOtoscope

Product Code Classifications

CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05713315000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05713315000072057133150000725713315000072

GMDN Terms

TermDefinition
Audiometer/otoscopeA battery-powered, hand-held device intended for: 1) visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening; and 2) evaluation of hearing by generating 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 presenting them to a patient (pure-tone audiometery). It consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the ear canal, a pitch generator (speaker), and is intended to be used with a detachable ear speculum which may be included. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
true
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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05713315007521MADSEN Astera 28-04-131248-04-131242024-12-12
05713315007859MADSEN Astera 28-04-131048-04-131042024-12-12
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05713315010279Madsen A4508-04-14660 8-04-14660 2022-12-28
05713315010286Madsen A4508-04-14661 8-04-14661 2022-12-28
05713315010293Madsen A4508-04-14662 8-04-14662 2022-12-28
05713315009464Madsen Zodiac8-04-163078-04-163072022-12-05
05713315010699Otoscan0432430432432023-05-11
05713315009969Bone Conductor (BC-2)0415450415452023-03-09
05713315010101Bone Conductor (BC-2)0415460415462023-03-09

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