FDA.reportPublic FDA data

Penlight

Primary DI
00786511240875
Brand
Penlight
Company
RASHMAN CORPORATION
Model
S214-ROY
Device description
Soft LED Pupil Gauge Penlight
Published
2022-12-02
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
00786511240875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786511240875007865112408757865112408750786511240875

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, reusableA noninvasive, hand-held, battery-powered unit intended to deliver a low-level electric current to break the connection between a vascular (neurovascular or peripheral) implantable device, and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the desired electrically unstable detachment point. 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
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
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
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
00811331011654TruBrite Adhesive Retractor LightTz Medical, Inc.KYT2023-10-20
00816835024254IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024261IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024278IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
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
00810114912034SurgiTelSurgitelKYT2023-01-12
00810114912041SurgiTelSurgitelKYT2023-01-12
00810114912058SurgiTelSurgitelKYT2023-01-12
00810114912065SurgiTelSurgitelKYT2023-01-12
00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099497Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11