FDA.report

Lighted Ear Curette™ Variety Clinic Pack

Primary DI
10859911004693
Brand
Lighted Ear Curette™ Variety Clinic Pack
Company
Bionix, LLC
Model
2209
Catalog number
2209
Device description
Clinic Pack: Lighted Variety
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

Related Records

Contact Domains

Product Codes

CodeName
JYGCURETTE, EAR

Product Code Classifications

CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00859911004696PrimaryGS10
10859911004693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004696008599110046968599110046960859911004696
1085991100469310859911004693

GMDN Terms

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

Contacts

PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags

DUNS number
117844489
Device count
200
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 DIBrandModelCatalogPublished
00714646001153Clearlook Lighted Variety Pack334533452023-08-12
00714646001344ClearLook Lighted Variety Pack, Refill344534452025-02-25
00714646001368ClearLook Lighted Variety Pack with Rechargeable Light Source364536452025-02-25
00714646001375Rechargeable Light Source360036002025-02-25
10714646001532Lighted Magnetic Foreign Body Removal Tool352535252026-03-03
00714646001627Lighted Magnetic Foreign Body Removal Tool352135212026-03-03
00714646000736OtoClear SprayWash System, Single Use Sample27291272912024-07-11
10859911004792Tabletop Waterpik Adapter Wands27210272102024-07-11
00714646001474Pelvis Belly Replacement Leg CushionPPRT-5101PPRT-51012025-08-21
00714646001481Pelvis Belly Replacement Arm Rest CushionPPRT-5103PPRT-51032025-08-21
00714646001498Pelvis Belly Replacement Stomach Cushion - MediumPPRT-5104PPRT-51042025-08-21
00714646001504Pelvis Belly Replacement Face Cushion AssemblyPPRT-5107PPRT-51072025-08-21
00714646001511Pelvis Belly Replacement Stomach Cushion - SmallPPRT-5108PPRT-51082025-08-21
10714646001099Microsuction Stater Pack2650LS-026502025-07-08
10714646001105Microsuction Replacement Pack2651LS-026512025-07-08
10714646001129Sample: Opti-Tatt24100241002025-06-20
00714646001382Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, ReplacementPBRT-6243PBRT-62432025-05-28
00714646001399Prone Breast, Face Cushion, ReplacementPBRT-6253PBRT-62532025-05-28
00714646001405Prone Breast, Arm Rest, ReplacementPBRT-6255PBRT-62552025-05-28
00714646001412Prone Breast, Leg Cushion, ReplacementPBRT-6270PBRT-62702025-05-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776418069MillenniumAvalign Technologies, Inc.JYG2026-03-23
00192896111783Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111790Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111806Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111813Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111820Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111837Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00190776416478MillenniumAvalign Technologies, Inc.JYG2026-02-16
00190776416485MillenniumAvalign Technologies, Inc.JYG2026-02-16
00757770672080Bausch + LombBausch & Lomb IncorporatedJYG2025-12-12
04250676716422Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-25
04250381855461Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855478Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855973Spoon curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855980Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855997Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856000Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856017Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856024Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856031Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856086Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856093Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856109Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856116Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863329Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863336Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863343Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863350Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381862490Tisch micro curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-11
00190776409357MillenniumAvalign Technologies, Inc.JYG2025-08-25