FDA.reportPublic FDA data

ABN Deluxe Penlight

Primary DI
08997021263526
Brand
ABN Deluxe Penlight
Company
SUGIH INSTRUMENDO ABADI, PT
Model
PL-900-212
Device description
ABN Deluxe Penlight is a medical device used as an assessment tool especially small body parts such as eyes, ears, nose, and mouth.
Published
2023-06-09
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
08997021263526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08997021263526089970212635268997021263526

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

Regulatory Flags#

DUNS number
726548899
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08997021260105ABN Precision Aneroid Sphygmomanometer, Adult, Black AS-0212025-07-25
08997021260112ABN Precision Aneroid Sphygmomanometer, Infant, BlackAS-0232025-07-25
08997021260129ABN Precision Aneroid Sphygmomanometer, Child, BlackAS-0252025-07-25
08997021260136ABN Precision Aneroid Sphygmomanometer, Large Adult, BlackAS-0262025-07-25
08997021260143ABN Precision Aneroid Sphygmomanometer, Thigh, BlackAS-0272025-07-25
08997021260754ABN Classic Stethoscope, Adult, BlackSS-021-BK2023-06-09
08997021260006ABN PREMIUM Aneroid Sphygmomanometer, Adult, BlackAS-0112023-06-09
08997021263472ABN Digital ThermometerDT-900-1012023-06-09
08997021263762Direct Supply - Attendant Handheld Aneroid SphygmomanometerDSA-HS2016-12-13
08997021263779Direct Supply - Attendant Mobile Clock Aneroid SphygmomanometerDSA-MS2016-12-13

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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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