FDA.reportPublic FDA data

NAR

Primary DI
00842209135158
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
20-0018
Catalog number
20-0018
Device description
SPECULA, ADULT DISPOSABLE - PKG/50 4.0 mm
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00842209135158PrimaryGS10
10842209135155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209135158008422091351588422091351580842209135158
1084220913515510842209135155

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.

Regulatory Flags#

DUNS number
832426782
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209112098NAR30-000630-00062022-11-15
00842209139255NAR Kit10-010310-01032026-07-06
00842209139262NAR85-515685-51562026-07-06
00842209139279NAR85-516985-51692026-07-06
00842209139286NAR80-0159-TLS80-0159-TLS2026-07-06
00842209139293NAR80-146180-14612026-07-06
00842209122691NAR85-12972022-12-08
00842209123926NAR80-09232022-12-08
00842209139149NAR10-000810-00082026-06-22
00842209139156NAR10-000910-00092026-06-22
00842209139163NAR10-001010-00102026-06-22
00842209139170NAR10-001110-00112026-06-22
00842209139187NAR10-001210-00122026-06-22
00842209139194NAR10-001310-00132026-06-22
00842209139200NAR10-001410-00142026-06-22
00842209139231NAR80-156280-15622026-06-22
00842209139248NAR85-515385-51532026-06-22
00842209138760NAR77-014377-01432026-05-27
00842209138777NAR77-014477-01442026-05-27
00842209138784NAR77-014577-01452026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809991035006Shim SPOTDOCTORSHIM KOREA INC.EPY2026-07-10
00850083275808Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275815Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275877Intrace USAPILOTIS TECH LLCEPY2026-07-03
00810158216594PRINCETONPrinceton Medical Group, Inc.EPY2026-06-23
00810189451704Surgical DesignSurgical Design, Inc.EPY2026-06-10
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
04250407704490FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704766FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704780FENTEXFENTEX medical GmbHEPY2022-12-07