FDA.reportPublic FDA data

Lighted AngleLoop®

Primary DI
10859911004525
Brand
Lighted AngleLoop®
Company
Bionix, LLC
Model
2210
Catalog number
2210
Device description
Lighted curette for cerumen removal
Published
2021-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00859911004528PrimaryGS10
10859911004525Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004528008599110045288599110045280859911004528
1085991100452510859911004525

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)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
50
DM exempt
true
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
007146460007432724527245272452024-07-11
007146460007502727527275272752024-07-11
0071464600098927247SP-27247272472022-10-27
00714646001535Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
10714646001532Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
00714646001627Lighted Magnetic Foreign Body Removal Tool352135212026-03-03
00714646001528Lighted Articulating Ear Curettes - Refill251225122025-11-22
00714646001559Rechargeable Light Source360036002025-11-22
00714646001566ClearLook Variety Pack with Rechargeable Light Source364536452025-11-22
00714646001573ClearLook LEC, Sample Pack-Curettes Only23300233002025-11-22
00714646001580ClearLook Variety Pack334533452025-11-22
00714646001597ClearLook CeraSpoon335033502025-11-22
00714646001603ClearLook Variety, 50ct Refill Pack344534452025-11-22
00714646001610ClearLook CeraSpoon, 50ct Refill Pack345034502025-11-22
00859911004160OtoClear Tips720072002017-01-28
00714646001092Lighted Microsuction System2650LS-026502025-07-08
00714646001108Microsuction Replacement Pack2651LS-026512025-07-08
00859911004795Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11
10859911004792Tabletop Waterpik Adapter Wands27210272102024-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20888277660196MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660233MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660240MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-05
00612479269538McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269569McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269590McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269620McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269651McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269682McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269712McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269743McKessonMCKESSON 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
20888277660219MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660226MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660257MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277669168MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20193489141495MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141501MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18