FDA.report

Robert La Roche

Primary DI
09010491030890
Brand
Robert La Roche
Company
RLR eyewear GesmbH
Model
CRS011-13
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
09010491030890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09010491030890090104910308909010491030890

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

Regulatory Flags

DUNS number
300407083
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
09010491001579Robert La Roche CR018-012022-11-14
09010491002002Robert La Roche CR018-0132022-11-14
09010491002019Robert La Roche CR018-022022-11-14
09010491002026Robert La Roche CR019-022022-11-14
09010491002033Robert La Roche CR019-032022-11-14
09010491002040Robert La Roche CR020-032022-11-14
09010491002057Robert La Roche CRS020-0132022-11-14
09010491002064Robert La Roche CRS020-062022-11-14
09010491002071Robert La Roche CRS021-012022-11-14
09010491002101Robert La Roche CR018-032022-11-14
09010491002118Robert La Roche CR019-012022-11-14
09010491002200Robert La Roche CR019-0132022-11-14
09010491002217Robert La Roche CR020-012022-11-14
09010491002224Robert La Roche CR020-022022-11-14
09010491002231Robert La Roche CR020-062022-11-14
09010491002248Robert La Roche CRS020-012022-11-14
09010491002255Robert La Roche CRS020-032022-11-14
09010491002262Robert La Roche CRS021-0112022-11-14
09010491002279Robert La Roche CRS021-01A2022-11-14
09010491002286Robert La Roche CRS021-072022-11-14

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