FDA.report

WALGREENS

Primary DI
00049022830516
Brand
WALGREENS
Company
WALGREEN CO.
Model
379015
Device description
WALG COPPER WRIST SPLINT - RIGHT
Published
2020-07-03
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
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10049022830513PackageGS124In Commercial Distribution
00049022830516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902283051310049022830513
00049022830516000490228305160490228305160049022830516

GMDN Terms

TermDefinition
Wrist orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-877-833-3324consumerrelations.pq@walgreens.com

Regulatory Flags

DUNS number
008965063
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

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