FDA.report

ROCAWEAR

Primary DI
00781268830232
Brand
ROCAWEAR
Company
Colors In Optics, Ltd.
Model
ROCAWEAR R3366 - GOLD/NUDE
Catalog number
R3366 GLDND
Device description
Sunglasses
Published
2022-07-24
Public version status
New
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

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
00781268830232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00781268830232007812688302327812688302320781268830232

GMDN Terms

TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(212)465-1200wpike@cio-usa.com

Regulatory Flags

DUNS number
060215290
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

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00781268845007TahariTAHARI TH906 - GOLD/TORTOISETH906 GLDTS2022-11-18
00781268844123Jessica SimpsonJ SIMPSON J6206 -BLACK/ANIMALJ6206 OXAN2022-11-16
00781268844130Jessica SimpsonJ SIMPSON J6206 - TORTOISE/NUDEJ6206 TSND2022-11-16
00781268844147Jessica SimpsonJ SIMPSON J6206 -WHITEJ6206 WH2022-11-16
00781268844154Jessica SimpsonJ SIMPSON J6211 - NUDE/PURPLEJ6211 NDPR2022-11-16
00781268844161Jessica SimpsonJ SIMPSON J6211 - ROSE/TORTOISEJ6211 RSTS2022-11-16
00781268844178Jessica SimpsonJ SIMPSON J6211 - BLACK/ANIMALJ6211 OXAN2022-11-16
00781268845014TahariTAHARI TH906 - ROSEGOLD/NUDETH906 RGDND2022-11-16
00781268845021TahariTAHARI TH906 - SILVER/WHITETH906 SLVWH2022-11-16
00781268845694Jessica SimpsonJ SIMPSON J6191 - BLACK/OATMEALJ6191 OXOAT2022-11-16
00781268845700Jessica SimpsonJ SIMPSON J6191 - NUDE/TORTOISEJ6191 NDTS2022-11-16
00781268845717Jessica SimpsonJ SIMPSON J6191 - TORTOISEJ6191 TS2022-11-16
00781268785020Colors in OpticsCOLORS CX128 - MBLK (+1.00)CX128 - MBLK (+1.00)2022-10-26
00781268785037Colors in OpticsCOLORS CX128 - MBLK (+1.50)CX128 - MBLK (+1.50)2022-10-26
00781268785044Colors in OpticsCOLORS CX128 - MBLK (+2.00)CX128 - MBLK (+2.00)2022-10-26
00781268785051Colors in OpticsCOLORS CX128 - MBLK (+2.50)CX128 - MBLK (+2.50)2022-10-26
00781268785068Colors in OpticsCOLORS CX128 - MBLK (+2.75)CX128 - MBLK (+2.75)2022-10-26
00781268785075Colors in OpticsCOLORS CX128 - MBLK (+1.75)CX128 - MBLK (+1.75)2022-10-26
00781268785082Colors in OpticsCOLORS CX128 - MBLK (+3.75)CX128 - MBLK (+3.75)2022-10-26
00781268785099Colors in OpticsCOLORS CX128 - TS (+1.00)CX128 - TS (+1.00)2022-10-26

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