FDA.reportPublic FDA data

N9 speculum

Primary DI
27290018446120
Brand
N9 speculum
Company
NONAGON LTD
Model
N/A
Catalog number
MHD-100-02-033
Device description
ENT ear speculum for Nonagon N9 device
Published
2021-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
27290018446120PrimaryGS10
07290018446126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729001844612027290018446120
07290018446126072900184461267290018446126

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
532283903
Device count
27
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018446154Nonagon N9+N9+2022-09-28
27290018446151Nonagon N9+ SmartExamN9+2022-09-28
07290018446102Nonagon N9MHD-100-02-0012021-05-26
07290018446126N9 speculumN/AMHD-100-02-0332021-09-13

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
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
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
00812594012518Ocular Exam Neonatal SpeculumNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012525Ocular Exam Standard SpeculumNEOTECH PRODUCTS, INC.FXG2021-06-14