FDA.reportPublic FDA data

Penlight

Primary DI
00786511629359
Brand
Penlight
Company
RASHMAN CORPORATION
Model
S200-BLK
Device description
Standard Disposable Penlight
Published
2022-12-05
Public version status
New
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
00786511629359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786511629359007865116293597865116293590786511629359

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker handpieceA manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it may include a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078803608
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00786511077938StethoscopeS121-AQS2022-12-06
00786511249236StethoscopeS120-BLK2022-12-06
00786511249243StethoscopeS120-ROY2022-12-06
00786511249250StethoscopeS120-PUR2022-12-06
00786511249267StethoscopeS120-SAS2022-12-06
00786511462192StethoscopeS108-HPK2022-12-06
00786511559113StethoscopeS108-STE2022-12-06
00786511563851StethoscopeS121-BLK2022-12-06
00786511566463StethoscopeS108-P-HPK2022-12-06
00786511566470StethoscopeS108-I-HPK2022-12-06
00786511566913StethoscopeS108-CBL2022-12-06
00786511624958StethoscopeS108-P-BLK2022-12-06
00786511629106StethoscopeS108-I-BLK2022-12-06
00786511629113StethoscopeS108-BLK2022-12-06
00786511629274StethoscopeS106-BLK2022-12-06
00786511769116StethoscopeS108-NAV2022-12-06
00786511869113StethoscopeS108-ROY2022-12-06
00786511879112StethoscopeS108-TEA2022-12-06
00786511939113StethoscopeS108-PUR2022-12-06
00786511077839StethoscopeS126-AQS2022-12-05

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