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
00842209140367NAR85-523385-52332026-10-14
00842209140374NAR85-523485-52342026-10-14
00842209140381NAR85-524085-52402026-10-14
00842209140398NAR Kit88-005088-00502026-10-14
00842209140404NAR80-0097-TLS80-0097-TLS2026-10-14
00842209140411NAR80-198980-19892026-10-14
00842209140428NAR80-201580-20152026-10-14
00842209140435NAR85-392785-39272026-10-14
00842209140442NAR85-523685-52362026-10-14
00842209140459NAR85-524185-52412026-10-14
00842209140466NAR85-524585-52452026-10-14
00842209140473NAR80-0494A80-0494A2026-10-14
00842209140480NAR80-1091A80-1091A2026-10-14
00842209140497NAR80-0951A80-0951A2026-10-14
00842209140503NAR80-1166A80-1166A2026-10-14
00842209140510NAR80-1157A80-1157A2026-10-14
00842209140527NAR82-0058A82-0058A2026-10-14
00842209140534NAR82-0076A82-0076A2026-10-14
00842209140541NAR82-0051A82-0051A2026-10-14
00842209140558NAR82-0055A82-0055A2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9210921080Surgical DirectSurgical Direct, Inc.EPY2026-10-20
00190776435165MillenniumAvalign Technologies, Inc.EPY2026-10-16
00190776435172MillenniumAvalign Technologies, Inc.EPY2026-10-16
00724995267391Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267407Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267414Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267421Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267445Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267452Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267469Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
00724995267476Snowden-PencerSTERIS Deutschland GmbHEPY2026-10-15
G141546073500Carnegie Surgical LLCCarnegie Surgical LLCEPY2026-09-30
D955SPCM1Paul BandittTerlain Enterprises, Inc.EPY2026-09-25
00190776432256MillenniumAvalign Technologies, Inc.EPY2026-09-24
00810238290094PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
04054462156481evonosevonos GmbH & Co. KGEPY2026-08-26
04054462902286evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902293evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902309evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902316evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902330evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902385evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902408evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902415evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902422evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902439evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902446evonosevonos GmbH & Co. KGEPY2026-08-21