FDA.reportPublic FDA data

Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybag

Primary DI
04030155000682
Brand
Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybag
Company
Kirchner & Wilhelm GmbH + Co KG
Model
01.71222.001
Catalog number
01.71222.001
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04030155000682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04030155000682040301550006824030155000682

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
315480269
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04030155013392MedCenter 5000 wall mounted set, ear funnels module02.84001.00202.84001.0022023-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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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
00812594012518Ocular Exam Neonatal SpeculumNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012525Ocular Exam Standard SpeculumNEOTECH PRODUCTS, INC.FXG2021-06-14