FDA.reportPublic FDA data

NAR

Primary DI
10842209135148
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
20-0017
Catalog number
20-0017
Device description
SPECULA, SMALL DISPOSABLE - PKG/50 2.5 mm
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00842209135141PrimaryGS10
10842209135148Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209135141008422091351418422091351410842209135141
1084220913514810842209135148

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
832426782
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00842209139620NAR84-0004A84-0004A2026-08-19
00842209139637NAR84-0007A84-0007A2026-08-19
00842209139644NAR84-0020A84-0020A2026-08-19
00842209139651NAR84-0023A84-0023A2026-08-19
00842209139668NAR84-0135A84-0135A2026-08-19
00842209139675NAR84-0138A84-0138A2026-08-19
00842209139682NAR80-1483A80-1483A2026-08-19
00842209139699NAR80-198580-19852026-08-19
00842209139705NAR84-020584-02052026-08-19
00842209139712NAR77-015377-01532026-08-19
00842209139729NAR82-0049P82-0049P2026-08-19
00842209139736NAR82-0051P82-0051P2026-08-19
00842209139743NAR82-0075P82-0075P2026-08-19
00842209139750NAR82-0077P82-0077P2026-08-19
00842209139767NAR80-1166P80-1166P2026-08-19
00842209139774NAR80-1593P80-1593P2026-08-19
00842209139781NAR80-1612P80-1612P2026-08-19
00842209139798NAR80-186980-18692026-08-19
00842209139804NAR80-189180-18912026-08-19
00842209139811NAR85-519685-51962026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
04054462902453evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902460evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902477evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902484evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902491evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902507evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902514evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902521evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902538evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904877evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904884evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904891evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904907evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904914evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904938evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904945evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904952evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904969evonosevonos GmbH & Co. KGEPY2026-08-21