e-scope® F.O. otoscope XL 2.5 V, black,

Primary DI
04045396176935
Brand
e-scope® F.O. otoscope XL 2.5 V, black,
Company
Rudolf Riester GmbH
Model
2111-202
Catalog number
2111-202
Device description
The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula
Published
2021-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932503000RI-MINIRudolf Riester GmbH & Co. KG1993-10-08ERA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396176935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396176935040453961769354045396176935

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537208717
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04045396195394Stethoscope duplex® 2.0 blue,4200-034200-032021-01-28

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