FDA.reportPublic FDA data

LightBeam

Primary DI
00810323005725
Brand
LightBeam
Company
EAR TECHNOLOGY CORPORATION
Model
LB-LSO
Device description
Replacement light source
Published
2022-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810323005725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810323005725008103230057258103230057250810323005725

GMDN Terms#

Term, Definition table
TermDefinition
ENT instrument light sourceAn electrically-powered, noninvasive device intended to be attached to the proximal end of an appropriate ear/nose/throat (ENT) instrument (e.g., curette or forceps) [not included] to produce light and facilitate visualization. It is designed for use with an instrument with light transmitting features; it is not intended for endoscopic use. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
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
00810323001871LightBeamLB07-Refill2022-05-09
00810323001888LightBeamLB08-Refill2022-05-09
00810323001895LightBeamLB09-Refill2022-05-09
00810323001901LightBeamLB-Variety2022-05-09
00810323005718LightBeamLB-Charger2022-05-09
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
Primary DIBrandCompanyProduct codePublished
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00724995271626V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271633V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271640V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271657V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271800V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
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00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31