FDA.reportPublic FDA data

Ocular Exam Neonatal Speculum

Primary DI
10812594012515
Brand
Ocular Exam Neonatal Speculum
Company
Neotech Products LLC
Model
10812594012515
Catalog number
N6500
Device description
Disposable Neonatal Speculum
Published
2021-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
10812594012515PrimaryGS10
00812594012518Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401251510812594012515
00812594012518008125940125188125940125180812594012518

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, single-useA self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
198013435
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812594010177NeoBridge®MicoN7002021-05-19
10812594010269NeoBridge®SmallN7012021-05-19
10812594010276NeoBridge®LargeN7022021-05-19
10812594010351EZ-Hold®StandardN7572021-05-19
10812594010726NeoGrip®BlueN602B2021-05-19
10812594010740NeoGrip®Pink & BlueN6022021-05-19
10812594010764NeoGrip®VersaGrip - LargeN6012021-05-19
10812594010788NeoGrip®WhiteN6032021-05-19
10812594011037Hold-A-Line™StandardN7052021-06-02
10812594011358EZ-Hold®MiniN7562021-05-19
10812594011952Telemetry TotesClip-ToteA5012021-06-14
10812594011969Telemetry TotesValu-ToteA5072021-06-14
10812594012096EZ-Hold®Extra LargeN7582021-05-19
10812594012102NeoGrip®RedN602R2021-05-19
10812594012119NeoGrip®Neon GreenN602G2021-05-19
10812594012126NeoGrip®YellowN602Y2021-05-19
10812594012133NeoGrip®OrangeN602O2021-05-19
10812594012140NeoGrip®VioletN602V2021-05-19
10812594012461NeoGrip®PinkN602P2021-05-19
20812594012925NeoSnug Small20812594012925N7015-152023-09-08

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
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
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