FDA.reportPublic FDA data

Glance

Primary DI
00787511810372
Brand
Glance
Company
SUN BAN FASHIONS (NEW YORK) INC.
Model
R037
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOISpectacle, Magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00787511810372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00787511810372007875118103727875118103720787511810372

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082596461
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00787511158801Glance15882022-12-01
00787511189201Glance18922022-12-01
00787511191808Glance19182022-12-01
00787511194601Glance19462022-12-01
00787511198005Glance19802022-12-01
00787511254909Glance25492022-12-01
00787511275003Glance27502022-12-01
00787511999992Glance999992022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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