FDA.reportPublic FDA data

econom® Vac. 2.7 V / XL 2.5 V,

Primary DI
04045396130593
Brand
econom® Vac. 2.7 V / XL 2.5 V,
Company
Rudolf Riester GmbH
Model
2052-200
Catalog number
2052-200
Device description
The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear speculaThe Riester ophthalmoscope is produced for the examination of the eye and the eyeground.The nasal speculum is produced for illumination and therefore examination of the inside of the nose.The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial woodenand plastic blades.The laryngeal mirrors are produced for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator.
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925754000ECONOMRudolf Riester GmbH & Co. KG1993-10-08EPY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396130593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396130593040453961305934045396130593

GMDN Terms#

Term, Definition table
TermDefinition
ENT diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

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
Primary DIBrandModelCatalogPublished
04045396000186Stethoscope cardiophon 2.0, burgundy4240-044240-042021-01-28
04045396006317Stethoscope duplex® baby, blue, aluminium,404140412021-01-28
04045396006324Stethoscope duplex® de luxe baby, blue,404240422021-01-28
04045396006348Stethoscope duplex® neonatal, blue, aluminium,405140512021-01-28
04045396006355Stethoscope duplex® de luxe neonatal,405240522021-01-28
04045396006430Stethoscope tristar, slate-grey, 3 chestpieces,409140912021-01-28
04045396006454Stethoscope tristar, blue, 3 chestpieces,409340932021-01-28
04045396118485Stethoscope duplex®, black, aluminium,4001-014001-012021-01-28
04045396118492Stethoscope duplex®, slate grey, aluminium,4001-024001-022021-01-28
04045396118683Teaching stethoscope duplex®, slate-grey,4002-024002-022021-01-28
04045396118867Stethoscope duplex®, blue, aluminium,4031-034031-032021-01-28
04045396119826Stethoscope anestophon, slate-grey, aluminium,4177-024177-022021-01-28
04045396119833Stethoscope anestophon, blue, aluminium,4177-034177-032021-01-28
04045396119857Stethoscope anestophon, green, aluminium,4177-054177-052021-01-28
04045396163546Stethoscope duplex® 2.0 blue,4210-034210-032021-01-28
04045396177390Stethoscope duplex® 2.0 baby, black,4220-014220-012021-01-28
04045396177406Stethoscope duplex® 2.0 neonatal, black4230-014230-012021-01-28
04045396195370Stethoscope duplex® 2.0 black4200-014200-012021-01-28
04045396195387Stethoscope duplex® 2.0 white,4200-024200-022021-01-28
04045396195394Stethoscope duplex® 2.0 blue,4200-034200-032021-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04250676750778Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
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04250676750976Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
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04250676751010Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751027Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
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04250676751058Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
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