FDA.report

e-xam LED 2.5 V, white

Primary DI
04045396198517
Brand
e-xam LED 2.5 V, white
Company
Rudolf Riester GmbH
Model
5131-02
Catalog number
5131-02
Device description
The Riester diagnostic light is used for examination.
Published
2021-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications

CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04045396198517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04045396198517040453961985174045396198517

GMDN Terms

TermDefinition
Hand-held examination/treatment lightA small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
537208717
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04045396007017Pack of 6 pcs. ri-pen® red507750772021-07-19
04045396120310ri-pen® blue5071-5265071-5262021-07-19
04045396120341ri-pen® green5072-5265072-5262021-07-19
04045396120389ri-pen® silver5074-5265074-5262021-07-19
04045396120464ri-pen® black5075-5265075-5262021-07-19
04045396120525ri-pen® red5077-5265077-5262021-07-19
04045396198487e-xam XL 2.5 V, black5130-015130-012021-07-19
04045396198562Pack of 6 pcs. ri-pen®, violett507850782021-07-19
04045396200517ri-pen® violett,5078-5265078-5262021-07-19
04045396000339RVS-200, NIBP(Riester) +SpO2(Nellcor) + Pred. Temp1961-RNBXU1961-RNBXU2021-07-19
04045396006942Pack of 6 pcs. ri-pen®507050702021-07-19
04045396006959Pack of 6 pcs. ri-pen®507150712021-07-19
04045396006966Pack of 6 pcs. ri-pen® green507250722021-07-19
04045396006980Pack of 6 pcs.ri-pen®507450742021-07-19
04045396006997Pack of 6 pcs. ri-pen®, black507550752021-07-19
04045396021686ri-integral flex flexible blade with integrated F.12250122502021-07-19
04045396121829metpak 3000 ml, latex free5270-5365270-5362021-07-19
04045396121836metpak 5000 ml, latex free5270-5375270-5372021-07-19
04045396147171ri-derma dermatoscope head LED 3.5 V,10577-30110577-3012021-07-19
04045396160613SuperVu Galilean 2.5x, at 34 cm working distance3960-6253960-6252021-07-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
04053755203314DELTA XHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203321DELTA X CPPHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203338DELTA X CPGHeine Optotechnik GmbH & Co. KGKYT2025-12-03
00851289007347FireflyFirefly GlobalKYT2025-07-18
04053755202928DELTAoneHeine Optotechnik GmbH & Co. KGKYT2025-04-30
07465850912003Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912010Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912027Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912034Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912041Dr. VampaDr Vampa S.R.L.KYT2025-03-10
00814005023526RADBL25Quality Aspirators, Inc.KYT2025-02-27
00814005023533RADBLC1Quality Aspirators, Inc.KYT2025-02-27
00814005023540RADFILM5Quality Aspirators, Inc.KYT2025-02-27
00814005023571RADHU2Quality Aspirators, Inc.KYT2025-02-27
00814005023595RADHUM4Quality Aspirators, Inc.KYT2025-02-27
00814005023618RADINST1Quality Aspirators, Inc.KYT2025-02-27
00814005024172RADC25Quality Aspirators, Inc.KYT2025-02-27
00814005024189RADFILM6Quality Aspirators, Inc.KYT2025-02-27
008140050242572 Pin Detachable CableQuality Aspirators, Inc.KYT2025-02-27
00814005024288M-CZQuality Aspirators, Inc.KYT2025-02-27
00814005024295M-ORTTL AssemblyQuality Aspirators, Inc.KYT2025-02-27
00814005024301M-COQuality Aspirators, Inc.KYT2025-02-27
00814005024370M-KEQuality Aspirators, Inc.KYT2025-02-27
00814005024387M-HBQuality Aspirators, Inc.KYT2025-02-27
00814005024394M-ORQuality Aspirators, Inc.KYT2025-02-27
00814005024400M-QFQuality Aspirators, Inc.KYT2025-02-27
00814005024431M-SUQuality Aspirators, Inc.KYT2025-02-27