FDA.report

Brendel

Primary DI
00764724309336
Brand
Brendel
Company
Tura Inc.
Model
916007 50 57
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00764724309336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00764724309336007647243093367647243093360764724309336

GMDN Terms

TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Device Sizes

TypeValueUnit
Width57Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
18003458872dtripp@tura.com

Regulatory Flags

DUNS number
968237318
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
00764724847975Ted Baker SunTMS091 RED 522022-12-01
00764724847982Ted Baker SunTMS091 GRY 522022-12-01
00764724847999Ted Baker SunTMS092 HON 572022-12-01
00764724848002Ted Baker SunTMS092 BLK 572022-12-01
00764724848163Ted Baker SunTMS094 HRN 512022-12-01
00764724848170Ted Baker SunTMS094 GRY 512022-12-01
00764724848200Ted Baker SunTMS093 OLI 552022-12-01
00764724848217Ted Baker SunTMS093 BLK 552022-12-01
00764724848255Ted BakerTWS159 COR 562022-12-01
00764724848262Ted BakerTWS159 BLU 562022-12-01
00764724848446LuluL177 GLD 572022-12-01
00764724848453LuluL177 RGD 572022-12-01
00764724848460LuluL178 AMB 562022-12-01
00764724848477LuluL178 IVO 562022-12-01
00764724848675Lulu SunL179 BLK 562022-12-01
00764724848682Lulu SunL179 SLA 562022-12-01
00764724849009Kate Young for TuraK574 BUR 542022-12-01
00764724849016Kate Young for TuraK574 KHA 542022-12-01
00764724849047Kate Young for TuraK575 BLK 552022-12-01
00764724849054Kate Young for TuraK575 GLD 552022-12-01

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