FDA.report

Walgreens

Primary DI
10049022739717
Brand
Walgreens
Company
WALGREEN CO.
Model
308024
Device description
WALG WRIST SUPPORT LEFT S/M
Published
2020-05-18
Public version status
New
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
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10049022739717PackageGS112In Commercial Distribution
00049022739710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902273971710049022739717
00049022739710000490227397100490227397100049022739710

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
1-800-925-4733consumerrelations.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
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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