FDA.reportPublic FDA data

EOS

Primary DI
04712568360866
Brand
EOS
Company
NORTH EOS INDUSTRIES INC.
Model
EosOtoSpec IV-GUTTER-VET. 6MM(HEINE)
Device description
EOS BRAND DISPOSABLE OTOSCOPE IV- GUTTER-Veterinary 6MM (HEINE)
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04712568360866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712568360866047125683608664712568360866

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, single-useA semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656812989
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712568360873EOSEosProbe2018-11-30
04712568360514EOSEosCurette-RING BLUE2018-08-10
04712568360521EOSEosCurette- SPOON GREEN2018-08-10
04712568360361EOSEosSuction2018-08-10
04712568360385EOSEyelidSpec2018-08-10
04712568360538EOSEosOtoSpec I - 4.5MM (Keeler)2018-08-15
04712568360545EOSEosOtoSpec I-3.5MM (Keeler)2018-08-15
04712568360552EOSEosOtoSpec I -2.5MM (Keeler)2018-08-15
04712568360569EOSEosOtoSpec I -5.5mm (Keeler)2018-08-15
04712568360583EOSEosOtoSpec II -4.25MM (WA)2018-08-15
04712568360590EOSEosOtoSpec II -2.75MM (WA)2018-08-15
04712568360781EOSEosOtoSpec III-2.5MM, LARGER(HEINE)2018-08-15
04712568360798EOSEosOtoSpec III-4.0MM,LARGER (HEINE)2018-08-15
04712568360804EOSEosOtoSpec III -(LOCK)2.5MM SMALLER (HEINE)2018-08-15
04712568360811EOSEosOtoSpec III (LOCK)-4.0MM SMALLER (HEINE)2018-08-15
04712568360828EOSEosOtoSpec IV- Veterinary 4MM2018-08-15
04712568360835EOSEosOtoSpec IV-Veterinary 6MM (HEINE)2018-08-15
04712568360842EOSEosOtoSpec IV-Veterinary 9MM (HEINE)2018-08-15
04712568360859EOSEosOtoSpec IV-GUTTER-VET. 4MM(HEINE)2018-08-15
04712568360927EOSEosStethoscope2018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811148858INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148889INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148957INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148919INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
09348811148933INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
G043608500BEARBear-Ent, LLCEPY2022-05-23
10381780503453Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503545Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780478591Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-18
10381780506300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-12
10381780403852Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780418993Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419006Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16