Walgreens

Primary DI
60311917164184
Company
WALGREEN CO.
Model
335539
Catalog number
WRX335539V1
Device description
Adhesive Eye Patch. 2 1/4 IN X 3 1/8 IN.
Published
2020-07-14
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
true

Related Records

Regulatory Flags

DUNS number
008965063
Device count
20
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10311917164189PackageGS124In Commercial Distribution
00311917164182PrimaryGS10
60311917164184Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10311917164189PackageGS124Case00311917164182In Commercial Distribution
00311917164182PrimaryGS10
60311917164184Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KGXTape And Bandage, Adhesive1General Hospital880.5240NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Eye patch, single-useA device intended to be used to close/cover one or both eyes to protect the eye after a procedure and/or as part of an ophthalmic therapeutic intervention (e.g., after cataract surgery or for the treatment of amblyopia). It is made of a synthetic or biological material. This is a single-use device.

Device Sizes

TypeValueText
Length2.25 Inch
Width3.13 Inch

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

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