FDA.reportPublic FDA data

ri-vision with slit retinoscope XL/LED 3,5V/120V,

Primary DI
04045396182660
Brand
ri-vision with slit retinoscope XL/LED 3,5V/120V,
Company
Rudolf Riester GmbH
Model
3796-203
Catalog number
3796-203
Device description
The slit/spot retinoscopes (also known as skiascopes) are produced to determine the refraction (ametropias) of the eye.
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
HKMRetinoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964338000RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOTRudolf Riester GmbH & Co. KG1997-01-09HKM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396182660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396182660040453961826604045396182660

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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06945095544210zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544302zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544470zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544524zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544531zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544562zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544579zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544814zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544852zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544876zumaxZumax Medical Co., LTDHKM2026-05-21
06945095543749zumaxZumax Medical Co., LTDHKM2026-05-18
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00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HKM2023-08-17
04053755193202BETA 200 RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
04053755193219BETA 200 RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
04053755191673BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
00732094098914Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
00732094098952Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
04045396010819ri-scope® retinoscope head slit XL 3.5 VRudolf Riester GmbHHKM2021-01-28
04045396129931ri-scope® retinoscope head slit XL 3.5 V,Rudolf Riester GmbHHKM2021-01-28
04045396140974ri-vision with retinoscope slit XL 3.5 V, C-handleRudolf Riester GmbHHKM2021-01-28
04045396182646ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
04045396182783ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
00732094087703Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087765Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16