FDA.reportPublic FDA data

Adlite™

Primary DI
00634782513221
Brand
Adlite™
Company
AMERICAN DIAGNOSTIC CORP
Model
351PZ
Catalog number
351PZ
Device description
Disposable Penlight, 6/pkg,White w/Pupil Gauge, Generic
Published
2016-11-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
00634782513221PackageGS110Not in Commercial Distribution
00634782813222PackageGS16Not in Commercial Distribution
00634782013288PrimaryGS10
00634782024529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782513221006347825132216347825132210634782513221
00634782813222006347828132226347828132220634782813222
00634782013288006347820132886347820132880634782013288
00634782024529006347820245296347820245290634782024529

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
10
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782902636Adcuff™ 920-011N920-011N2026-02-23
00634782101695ADC®381N381N2026-02-20
00634782903213ADC®380N380N2026-02-20
00634782903190Advantage™611561152025-11-24
00634782903152Advantage™611261122025-09-19
00634782903169Advantage™612161212025-09-19
00634782903176Advantage™6121SA6121SA2025-09-19
00634782903183Advantage™6121X6121X2025-09-19
00634782903091Adtemp™ 424N-40424N-402025-02-05
00634782603106Adtemp™ 424N-200424N-2002025-02-05
00634782903039Adtemp™ 424N424N2025-01-29
00634782600402Adscope®608LPST608LPST2023-01-11
00634782600600Adscope®600IMCA600IMCA2023-01-10
00634782600617Adscope®600IST600IST2023-01-10
00634782600624Adscope®601IMCA601IMCA2023-01-10
00634782600631Adscope®601IST601IST2023-01-10
00634782600648Adscope®601RGBK601RGBK2023-01-10
00634782600655Adscope®608RGBK608RGBK2023-01-10
00634782600662Adscope®608RGW608RGW2023-01-10
00634782600679Adscope®606RGBK606RGBK2023-01-10

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
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