FDA.reportPublic FDA data

MedSource Disposable Pen Light

Primary DI
00816703028926
Brand
MedSource Disposable Pen Light
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-PEL100-RCS
Catalog number
Not Applicable
Device description
Disposable Pen Light w/Pupil Gauge
Published
2021-08-05
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
00816703028940PackageGS150In Commercial Distribution
00816703028926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703028940008167030289408167030289400816703028940
00816703028926008167030289268167030289260816703028926

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
041674552
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03
00840155404540MedSource BagsMS-B33655FPNot Applicable2021-07-28
00840155404670MedSource BagsMS-B3362Not Applicable2021-07-28
00840155407411MedSource BagsMS-B3350RNot Applicable2021-07-28
00840155406667MedSource BagsMS-B3309Not Applicable2021-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814005025650Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025667Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025674Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
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
00814005024448M-SUTTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024455M-SVQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024462M-TTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024479RADFIL1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024486RADFIL2QUALITY ASPIRATORS, INC.KYT2025-02-27