FDA.report

NeoShade Micro (Low-Profile) Hook

Primary DI
00812594010934
Brand
NeoShade Micro (Low-Profile) Hook
Company
NEOTECH PRODUCTS, INC.
Model
10812594010931
Catalog number
N724
Device description
Phototherapy Eye Shield (Qty. 50)
Published
2021-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FOKPad, Neonatal Eye

Product Code Classifications

CodeDeviceSpecialtyClass
FOKPad, Neonatal EyeGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10812594010931PrimaryGS10
00812594010934Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081259401093110812594010931
00812594010934008125940109348125940109340812594010934

GMDN Terms

TermDefinition
Eye maskA mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.

Sterilization Methods

Method

Regulatory Flags

DUNS number
198013435
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00812594011405Little Sucker Cover10812594011402N2152022-05-23
10812594010795Meconium Aspirator10812594010795N4012016-09-20
10812594010818Meconium Aspirator Tinted10812594010818NO1022016-09-20
10812594012584NeoBond Shapes (Hearts) (N7426)10812594012584N74262017-04-07
00812594010330NeoBond10812594010337N7412021-06-15
00812594011603NeoBond10812594011600N7422021-06-15
00812594012198EZCare Softouch - Pink10812594012195N9106PK2021-06-15
00812594012204EZCare Softouch - Pink10812594012201N9107PK2021-06-15
00812594012211EZCare Softouch - Pink00812594012211N9108PK2021-06-15
00812594012228EZCare Softouch - Pink10812594012225N9109PK2021-06-15
00812594012235EZCare Softouch - Pink10812594012232N9110PK2021-06-15
00812594012242EZCare Softouch - Pink10812594012249N9111PK2021-06-15
00812594012259EZCare Softouch - Tan10812594012256N9105TN2021-06-15
00812594012266EZCare Softouch - Tan10812594012263N9106TN2021-06-15
00812594012273EZCare Softouch - Tan10812594012270N9107TN2021-06-15
00812594012280EZCare Softouch - Tan10812594012287N9108TN2021-06-15
00812594012297EZCare Softouch - Tan10812594012294N9109TN2021-06-15
00812594012303EZCare Softouch - Tan10812594012300N9110TN2021-06-15
00812594012310EZCare Softouch - Tan10812594012317N9111TN2021-06-15
00812594012334EZCare Softouch - Blue10812594012331N9106BL2021-06-15

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00817770025832EyeMax2MAXTEC, LLCFOK2023-06-12
20190676001938POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
20190676001945POSEYPOSEY PRODUCTS, LLCFOK2022-10-06
00190676001927POSEY EYE PROTECTORSPOSEY PRODUCTS, LLCFOK2022-08-04
00817770022411EyeMax2MAXTEC, LLCFOK2021-10-25
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
50749756562527DeRoyalDEROYAL INDUSTRIES, INC.FOK2021-07-12
00812594010217NeoShades Small with TabsNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594010224NeoShades with Tabs MicroNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594010231NeoShades Large with TabsNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594013102NeoShades Blank Micro No Indentation with TabsNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594013119NeoShades Blank Micro No Indentation with HeadStrapNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594013126NeoShades Blank Small No Indentation with TabsNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594013133NeoShades Blank Small No Indentation with HeadStrapNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594013140NeoShades Blank Large No Indentation with TabsNEOTECH PRODUCTS, INC.FOK2021-05-19
00812594010873NeoShades Micro HeadstrapNEOTECH PRODUCTS, INC.FOK2021-05-18
00812594010897NeoShade Small HeadstrapNEOTECH PRODUCTS, INC.FOK2021-05-18
00812594010910NeoShades Large HeadstrapNEOTECH PRODUCTS, INC.FOK2021-05-18
00812594010958NeoShade Small (Low-Profile) HookNEOTECH PRODUCTS, INC.FOK2021-05-18
00812594010972NeoShade Large (Low-Profile) HookNEOTECH PRODUCTS, INC.FOK2021-05-18