FDA.reportPublic FDA data

Diagnostic station ri-former® 2 handles, 3 pin-plu

Primary DI
04045396134768
Brand
Diagnostic station ri-former® 2 handles, 3 pin-plu
Company
Rudolf Riester GmbH
Model
3652-300.001
Catalog number
3652-300.001
Device description
The ri-former® Diagnostic Station was manufactured for use with various instrument heads and modular components for non-invasivediagnostics.
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
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950914000RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/VRudolf Riester GmbH & Co. KG1995-07-24HLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04045396134768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04045396134768040453961347684045396134768

GMDN Terms#

Term, Definition table
TermDefinition
ENT examination/treatment systemAn assembly of devices intended to support a patient in a supine or reclining position and provide specialized features for an ear/nose/throat (ENT) examination or treatment. It typically includes a table and/or chair and functional components such as a suction/blowing apparatus, equipment drawers, and a mirror heater.

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
Primary DIBrandCompanyProduct codePublished
M368122731LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
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