FDA.report

Clear Care Rinse & Go

Primary DI
00300650146142
Brand
Clear Care Rinse & Go
Company
Alcon Laboratories, Inc.
Model
Clear Care Rinse & Go 4oz
Device description
Clear Care Rinse & GO Rinsing Solution 4 oz.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LPNAccessories, soft lens products

Product Code Classifications

CodeDeviceSpecialtyClass
LPNAccessories, Soft Lens ProductsOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20300650146146PackageGS124In Commercial Distribution
00300650146142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030065014614620300650146146
00300650146142003006501461423006501461420300650146142

GMDN Terms

TermDefinition
Contact lens rinsing solutionA sterile solution intended to be used to rinse debris or chemical agents from contact lenses (soft or rigid) prior to insertion; it may be intended to be used during storage or heat disinfection of contact lenses, or to dilute other contact lens solutions (e.g., contact lens protein-removal solution). It is an aqueous saline solution containing preservatives [e.g., edetate disodium (EDTA)] and buffering agents; it does not contain disinfecting, protein-removal, cleaning, or wetting agents. After application, this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)241-5999web.masterus@alcon.com

Regulatory Flags

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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