FDA.report

Ernest Hemingway

Primary DI
00754317198546
Brand
Ernest Hemingway
Company
New York Eye
Model
H4734-TOR-49
Device description
H-4734 TORTOISE 49/24/145
Published
2020-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00754317198546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00754317198546007543171985467543171985460754317198546

GMDN Terms

TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods

Method

Regulatory Flags

DUNS number
021529771
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00754317228700Valerie SpencerVS9466-CRY-542026-02-20
00754317187878EsquireEQ7903-BLK-532024-06-06
00754317187885EsquireEQ7903-TOR-532024-06-06
00754317187892EsquireEQ7904-BLK-502024-06-06
00754317187908EsquireEQ7904-MBK-502024-06-06
00754317187915EsquireEQ7904-MTO-502024-06-06
00754317187922EsquireEQ7904-TOR-502024-06-06
00754317187939EsquireEQ7905-BKC-512024-06-06
00754317187946EsquireEQ7905-TOR-512024-06-06
00754317187984EsquireEQ7907-BLC-532024-06-06
00754317187991EsquireEQ7907-CRY-532024-06-06
00754317188011EsquireEQ7901-TOR-602024-06-06
00754317188028EsquireEQ7908-BLK-532024-06-06
00754317188035EsquireEQ7908-TOR-532024-06-06
00754317188042EsquireEQ7908-CRY-532024-06-06
00754317188059EsquireEQ7917-BRN-572024-06-06
00754317188066EsquireEQ7917-GLD-572024-06-06
00754317188073EsquireEQ7918-BLK-582024-06-06
00754317188080EsquireEQ7918-BRN-582024-06-06
00754317188097EsquireEQ7918-GLD-582024-06-06

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