FDA.report

Well at Walgreens

Primary DI
10049022739229
Brand
Well at Walgreens
Company
WALGREEN CO.
Model
307746
Device description
WALG HAND SUPPRT GLV SM/MD
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10049022739229PackageGS112In Commercial Distribution
00049022739222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902273922910049022739229
00049022739222000490227392220490227392220049022739222

GMDN Terms

TermDefinition
Assistive dynamic arm support systemAn assembly of mechanical devices designed to bear the weight of a weak or paralysed arm providing gravity-compensating support for the functional use and/or rehabilitation of the arm/wrist/hand. It is used to support activities of daily life (ADL) such as feeding, self care, computer use, as well as therapeutical training and prevention of complaints of neck and/or shoulder (CANS). It consists of a main column anchored to a surface or wheelchair and a suspended sling or a set of components which take the weight bearing through a set of axes, joints, and a splint underneath the user's arm. Gravity compensation works via a counterweight or spring mechanism and a power-assistive electromotor.

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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