FDA.reportPublic FDA data

LightBeam

Primary DI
00810323001871
Brand
LightBeam
Company
EAR TECHNOLOGY CORPORATION
Model
LB07-Refill
Device description
50 pieces of Lighted Small Circle Loop Curette
Published
2022-05-09
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
00810323001871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810323001871008103230018718103230018710810323001871

GMDN Terms#

Term, Definition table
TermDefinition
ENT illuminating foreign body extraction setA collection of devices which includes a foreign body extraction instrument (typically a curette or forceps), and an electrically-powered light source, and a magnifying lens intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. This is a reusable set which may include some disposable devices.

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
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810323000003LightBeamLB10-refill2024-01-31
00810323009631TweakFocus+T otc2023-08-14
00810323001918LightBeamLB05-Refill2023-06-01
00810323001840LightBeamLB04-Refill2022-05-09
00810323001857LightBeamLB05-Refill2022-05-09
00810323001864LightBeamLB06-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

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Primary DI, Brand, Company table
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04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908141evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908158evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908165evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908172evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908189evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
04054462901685evonosevonos GmbH & Co. KGJYG2026-08-18
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00190776422370MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31
00190776403331MillenniumAvalign Technologies, Inc.JYG2026-07-21
00190776400637MillenniumAvalign Technologies, Inc.JYG2026-07-19
00190776395469MillenniumAvalign Technologies, Inc.JYG2026-07-14
09348811100603INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
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09348811100832INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
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