FDA.reportPublic FDA data

Posey Eye Protection

Primary DI
10852788008160
Brand
Posey Eye Protection
Company
NEOLIGHT LLC
Model
NL-EP-01S-PREMIE
Device description
Eye protection for newborn phototherapy - sized for premie patients
Published
2020-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOKPad, Neonatal Eye

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOKPad, Neonatal EyeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20852788008167PackageGS15In Commercial Distribution
10852788008160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085278800816720852788008167
1085278800816010852788008160

GMDN Terms#

Term, Definition table
TermDefinition
Eye padA cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.

Regulatory Flags#

DUNS number
074301687
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852788008101NeoLight Bassinet Basket Loaner300064NEO-BASK-LNR2025-04-09
00852788008019NeolightPCI 40-10032025-01-26
00852788008026NeolightPCI 40-10042025-01-26
00852788008040NeolightPCI 40-10172025-01-26
00852788008057NeolightPCI 40-10302025-01-26
00852788008064NeolightPCI 30-10002025-01-26
00852788008071NeolightPCI 40-10052025-01-26
10852788008085NeolightPCI 40-10022025-01-26
20852788008020NeolightPCI 40-1100FA2025-01-26
20852788008037NeolightPCI 40-1100 2025-01-26
20852788008044NeolightPCI 40-21002025-01-26
20852788008051NeolightPCI 40-2100FA2025-01-26
00852788008217NeoLight Bassinet Basket300063NEO-BASK2024-12-31
10852788008054Light ModuleNL-SK-32018-11-09
10852788008047CloudCover PlusNL-SK-8SNL-SK-8S2020-11-11
10852788008177CloudCoverNL-SK-5SNL-SK-5S2020-11-11
10852788008009Skylife LightbedNL-SK-22018-11-09
10852788008016Skylife ControllerNL-SK-12018-11-09
10852788008023GelMatNL-SK-2-2122018-11-09
10852788008078Skylife SystemNL-SK2018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315011764BilibandNatus Medical Denmark ApSFOK2025-10-14
05713315011771BilbandNatus Medical Denmark ApSFOK2025-10-14
05713315011788BilibandNatus Medical Denmark ApSFOK2025-10-14
00850018561273WeeSpecs Infant Eye ProtectionINTERNATIONAL BIOMEDICAL, LTD.FOK2023-06-21
00817770020561EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025818EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025825EyeMax2MAXTEC, LLCFOK2023-06-12
00817770025832EyeMax2MAXTEC, LLCFOK2023-06-12
10190676001931POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
10190676001948POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001938POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001945POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
10190676001924POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00190676001927POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00817770022411EyeMax2MAXTEC, LLCFOK2021-10-25
00749756139588DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139595DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139601DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139618DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756139625DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756173872DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756562515DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00749756562522DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139583DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139590DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139606DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139613DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756139620DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756173877DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
50749756562510DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12