FDA.report

Walgreens

Primary DI
10049022754819
Brand
Walgreens
Company
WALGREEN CO.
Model
317933
Device description
WALG WRIST SUPPORT ONE SIZE
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
10049022754819PackageGS112In Commercial Distribution
00049022754812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902275481910049022754819
00049022754812000490227548120490227548120049022754812

GMDN Terms

TermDefinition
Wrist binder, reusableA dedicated strip/roll of fabric or polymer material designed to be wrapped around the wrist to support the wrist joint. It does not include a rigid support (i.e., not a wrist immobilizer) and is not a tubular support bandage. 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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