FDA.reportPublic FDA data

Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs.

Primary DI
04030155000644
Brand
Ear funnel, grey, small, Ø 2,5 mm, PU = 1000 pcs.
Company
Kirchner & Wilhelm GmbH + Co KG
Model
01.71211.002
Catalog number
01.71211.002
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXGSpecula Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXGSpecula AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04030155000644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04030155000644040301550006444030155000644

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
315480269
Device count
1
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
04030155000675Ear funnel, grey, large, Ø 4,0 mm, PU = 1000 pcs.01.71221.00201.71221.0022026-06-25
04030155008480MedCharge 4000 battery charger compl. with mains adaptor12.80005.00212.80005.0022025-10-27
04030155004819Colorscop-duo stethoscope, pink06.22100.13406.22100.1342023-09-12
04030155004970Standard-Prestige stethoscope stainless steel, black06.22700.02206.22700.0222023-09-12
04030155005076Planet double stethoscope according to Fassbender06.22900.02206.22900.0222023-09-12
04030155005168Ear tips, black, Ø 5,5 mm, PU: 10 pcs. W. white turned parts06.91111.02106.91111.0212023-09-12
04030155011695Stethoscope double tube, black, length 60cm06.93265.02106.93265.0212023-09-12
04030155019448Planet Air stethoscope06.22910.12206.22910.1222023-09-12
04030155004987Standard-Prestige stethoscope stainless steel, blue06.22700.03206.22700.0322024-01-11
04030155004994Standard-Prestige stethoscope stainless steel, burgundy06.22700.17206.22700.1722024-01-11
04030155005007Baby-Prestige stethoscope stainless steel, black06.22701.02206.22701.0222024-01-11
04030155005038Children-Prestige stethoscope stainless steel, blue06.22702.03206.22702.0322024-01-11
04030155018960Children-Prestige stethoscope stainless steel, black06.22702.02206.22702.0222024-01-11
04030155019011Baby-Prestige stethoscope stainless steel, blue06.22701.03206.22701.0322024-01-11
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.01.72213.0012024-07-24
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure01.21300.00101.21300.0012023-09-04
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope02.11001.00202.11001.0022023-09-04
04030155010346PICCOLIGHT C otoscope, sky with ear funnels, cloth bag01.13100.23201.13100.2322023-09-04
04030155010353PICCOLIGHT C otoscope, stone with ear funnels, cloth bag01.13100.26201.13100.2622023-09-04
04030155010414PICCOLIGHT F.O. LED standard, otoscope, stone01.13500.26201.13500.2622023-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04030155000675Ear funnel, grey, large, Ø 4,0 mm, PU = 1000 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2026-06-25
00850071684308REALSTAR SURGICAL INSTRUMENTSREAL STAR SURGICAL INSTRUMENTSFXG2025-09-09
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2024-07-24
00840183503987BR Surgical, LLCBR Surgical, LLCFXG2024-02-06
00190776317799MillenniumAvalign Technologies, Inc.FXG2023-11-13
04030155000613Ear funnel, black, small Ø 2.5 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000637Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000651Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000668Ear funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000682Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000699Ear funnel, large, grey, Ø 4.0 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
00190776042479AvalignAvalign Technologies, Inc.FXG2023-06-23
00840183506872BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
00840183510725BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
14026704806307PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
54026704806305PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
00842331151125Novo Surgical Inc. NOVO SURGICAL, INC.FXG2022-11-12
00887482116463Symmetry SheaASPEN SURGICAL PRODUCTS, INC.FXG2022-09-29
27290018446120N9 speculumNONAGON LTDFXG2021-09-13
07290018446126N9 speculumNONAGON LTDFXG2021-09-13
10812594011853Neotech Ocular Exam KitNeotech Products LLCFXG2021-06-14
10812594012485Neonatal Ocular Exam Kit 2-packNeotech Products LLCFXG2021-06-14
10812594012492Neotech Ocular Exam KitNeotech Products LLCFXG2021-06-14
10812594012508Ocular Exam DepressorNeotech Products LLCFXG2021-06-14
10812594012515Ocular Exam Neonatal SpeculumNeotech Products LLCFXG2021-06-14
10812594012522Ocular Exam Standard SpeculumNeotech Products LLCFXG2021-06-14
00812594011856Ocular Exam Kit NeonatalNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012488Neonatal Ocular Exam Kit 2-packNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012495Ocular Exam Kit StandardNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012501Ocular Exam DepressorNEOTECH PRODUCTS, INC.FXG2021-06-14