FDA.reportPublic FDA data

Reusable Penlight

Primary DI
00616784478210
Brand
Reusable Penlight
Company
Dynarex Corporation
Model
4782
Device description
Reusable Penlight- LED with pupil gauge
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784478227PackageGS150In Commercial Distribution
00616784478234PackageGS16In Commercial Distribution
00616784478210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784478227006167844782276167844782270616784478227
00616784478234006167844782346167844782340616784478234
00616784478210006167844782106167844782100616784478210

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600301072021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) Filter301122021-04-22
00840117305410Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult302012021-04-22
00840117305434Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port302032021-04-22
00840117305458Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube302042021-04-22
00840117305472Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric302052021-04-22
00840117305496Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME) 50302102021-04-22
00840117305557Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303022021-04-22
00840117305885Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port303092021-04-22
00840117312340Resp-O2 Tracheostomy Drain Sponges, Non-woven,4"x4", 6-Ply350502022-05-02
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube302022021-04-22
00840117318113Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303032021-04-22
00840117318137Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303052021-04-22
00840117305519Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303002022-05-10
00840117305533Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303012022-05-10
00840117313545Resp-O2 Disposable Suction Canisters, 800 cc, Float Valve Shutoff, Locking Lid322012022-04-28
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22

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Primary DI, Brand, Company table
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B366LED0204PORTALEDEclerisKYT2026-01-23
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B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
07290016672763TytoHomeTYTO CARE LTDKYT2024-05-26
04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
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00816835024285IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024292IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00810132041792HCSConcordance Healthcare Solutions LLCKYT2023-07-28
00810114912010SurgiTelSurgitelKYT2023-01-12
00810114912027SurgiTelSurgitelKYT2023-01-12
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