FDA.reportPublic FDA data

EOS

Primary DI
04712568360798
Brand
EOS
Company
NORTH EOS INDUSTRIES INC.
Model
EosOtoSpec III-4.0MM,LARGER (HEINE)
Device description
EOS BRAND DISPOSABLE OTOSCOPE III - 4.0MM LARGER (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
04712568360798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712568360798047125683607984712568360798

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
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
04712568360866EOSEosOtoSpec IV-GUTTER-VET. 6MM(HEINE)2018-08-15
04712568360927EOSEosStethoscope2018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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