FDA.report

CDC

Primary DI
10840986015875
Brand
CDC
Company
APOTHECARY PRODUCTS, LLC
Model
K1010CD
Device description
ECONO-MATE LENS CASE
Published
2017-03-06
Public version status
Update
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
LRXCase, Contact Lens

Product Code Classifications

CodeDeviceSpecialtyClass
LRXCase, Contact LensOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840986015875PackageGS16In Commercial Distribution
20840986015872PackageGS16In Commercial Distribution
00840986015878PrimaryGS10
40077602010100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084098601587510840986015875
2084098601587220840986015872
00840986015878008409860158788409860158780840986015878
4007760201010040077602010100

GMDN Terms

TermDefinition
Contact lens caseA container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
952-890-1940udi@apothecaryproducts.com

Regulatory Flags

DUNS number
092312735
Device count
2
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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