FDA.reportPublic FDA data

LightBeam

Primary DI
00810323000003
Brand
LightBeam
Company
EAR TECHNOLOGY CORPORATION
Model
LB10-refill
Device description
50 Pieces of Lighted Tamper Curette
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYGCurette, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810323000003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810323000003008103230000038103230000030810323000003

GMDN Terms#

Term, Definition table
TermDefinition
Endaural wax extraction curetteA hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure; it is not intended for surgical scraping or manipulation of tissues. It may have various designs (e.g., serrated or blunt loop, hook, straight or curved), and may include a magnifying lens and/or light source. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)327-8547sstahmer@eartech.com

Regulatory Flags#

DUNS number
023930584
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810323009631TweakFocus+T otc2023-08-14
00810323001918LightBeamLB05-Refill2023-06-01
00810323001840LightBeamLB04-Refill2022-05-09
00810323001857LightBeamLB05-Refill2022-05-09
00810323001864LightBeamLB06-Refill2022-05-09
00810323001871LightBeamLB07-Refill2022-05-09
00810323001888LightBeamLB08-Refill2022-05-09
00810323001895LightBeamLB09-Refill2022-05-09
00810323001901LightBeamLB-Variety2022-05-09
00810323005718LightBeamLB-Charger2022-05-09
00810323005725LightBeamLB-LSO2022-05-09
00810323005732LightBeamLB-Magnifier2022-05-09
00810323001802LightBeamLB-Complete2022-05-06
00810323001819LightBeamLB01-Refill2022-05-06
00810323001826LightBeamLB02-Refill2022-05-06
00810323001833LightBeamLB03-Refill2022-05-06
00810323002540ClikClik2020-02-11
00810323003806TransEarTE380none2016-10-06
08103230025453ClikClik2020-02-11
08103230003802TransEarTE380none2016-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100566INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100573INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100818INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100849INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100856INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
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00612479269590McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00194613018269MSI Precision Specialty InstrumentsMed Saver, Inc.JYG2024-08-15
08904461000321OSSEOUS Rosen InserterEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319620OSSEOUS Jobson Horne Probe-RoundEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319637OSSEOUS Jobson Horne Probe-OvalEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319644OSSEOUS Cerumen hookEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319668OSSEOUS Myringotomy knifeEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
20888277660202MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
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20193489141495MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
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20193489141518MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141525MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18