FDA.reportPublic FDA data

Bose Frames

Primary DI
10017817827543
Brand
Bose Frames
Company
BOSE CORPORATION
Model
BMD0011
Catalog number
851338-0110R
Device description
Tenor style refurbished sunglasses, prescription ready frame in the US only.
Published
2022-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10017817827543PackageGS112In Commercial Distribution
00017817827546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001781782754310017817827543
00017817827546000178178275460178178275460017817827546

GMDN Terms#

Term, Definition table
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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-230-5639xx@xx.xx

Regulatory Flags#

DUNS number
002579431
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017817812818Bose Frames BMD0005833416-010R2021-07-08
00017817812825Bose Frames BMD0006833417-010R2021-07-08
00017817819978Bose Frames BMD0011851338-01102021-01-29
00017817820714Bose Frames BMD0011851336-01102021-01-29
00017817822053Bose Frames BMD0007840667-010R2021-07-08
00017817826716Bose Frames BMD0010839767-0110R2022-01-14
00017817827522Bose Frames BMD0011851336-011R2022-03-31
00017817827546Bose Frames BMD0011851338-0110R2022-01-14
00017817839518Bose Frames BMD0007840667-01002022-01-14
00017817839525Bose Frames BMD0010839767-01102022-01-14
00017817839532Bose Frames BMD0011851336-0112022-01-14
00017817839549Bose Frames BMD0011851338-01102022-01-14
00017817839556Bose Frames BMD0005833416-01002022-01-14
00017817810012Bose Frames BMD0010839767-01102021-01-29
00017817805698Bose Frames BMD0006833417-01002020-09-30
00017817805704Bose Frames BMD0005833416-01002020-09-30
00017817806657Bose Frames BMD0004834495-01002020-09-30
00017817806664Bose Frames BMD0003834494-01002020-09-30
00017817811538Bose Frames BMD0007840667-01002020-09-30
00017817827416Bose SoundControl Hearing AidBMD0012861812-03002021-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
08908016666505SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666529SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666536SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666635SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
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08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
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