FDA.reportPublic FDA data

Lighted Forceps for Foreign Body Removal

Primary DI
10859911004709
Brand
Lighted Forceps for Foreign Body Removal
Company
Bionix, LLC
Model
2750
Catalog number
2750
Device description
Lighted Forceps
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
KAEFORCEPS, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859911004702PrimaryGS10
10859911004709Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911004702008599110047028599110047020859911004702
1085991100470910859911004709

GMDN Terms#

Term, Definition table
TermDefinition
ENT foreign body extraction forcepsA hand-held, manual, non-surgical device 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. It is a rod with small jaws at its distal end which are controlled by pressing its handle; it may also 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)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
10
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405908MillenniumAvalign Technologies, Inc.KAE2026-07-26
00190776404147MillenniumAvalign Technologies, Inc.KAE2026-07-24
00190776403874MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403911MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403782MillenniumAvalign Technologies, Inc.KAE2026-07-21
04046826110833MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-07-21
00190776402198MillenniumAvalign Technologies, Inc.KAE2026-07-19
00190776395353MillenniumAvalign Technologies, Inc.KAE2026-07-14
00850083275785Intrace USAPILOTIS TECH LLCKAE2026-07-03
00850083275860Intrace USAPILOTIS TECH LLCKAE2026-07-03
04054462923465evonosevonos GmbH & Co. KGKAE2026-06-26
00810220800294Adler Instrument CompanyAdler, Inc.KAE2026-06-02
09348811022066INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-06-02
09348811105417INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-05-29
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21
09348811129024INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-19
08906039316018OSSEOUS Titanium-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316025OSSEOUS Fluoroplastic-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316032OSSEOUS Stapes Prosthesis Crimping ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04