FDA.reportPublic FDA data

Well at Walgreens

Primary DI
00049022759855
Brand
Well at Walgreens
Company
WALGREEN CO.
Model
319684
Device description
WALG WRST SPLNT REVADJ OS
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10049022759852PackageGS112In Commercial Distribution
00049022759855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004902275985210049022759852
00049022759855000490227598550490227598550049022759855

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917034218Walgreens7654302023-07-11
00311917034249Walgreens7654262023-07-11
00311917077932Walgreens7394332026-10-14
00311917090498Walgreens4172342026-10-12
00311917088556Walgreens3119170885562026-09-30
00311917086521Walgreens1439332026-09-28
00311917156064WALGREENS2576322020-07-22
00311917080062Walgreens7610162026-08-26
00311917086569Walgreens1666772026-08-21
00311917086590Walgreens1666372026-08-21
00311917122045Walgreens5052882023-03-09
00311917158952Walgreens276743WRX2767432020-07-14
00311917014876Walgreens6772599288502016-12-20
00311917048130Walgreens6548789288562016-12-20
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226443006ViveVIVE HEALTH LLCILH2026-10-20
00194346210794EquateWAL-MART STORES, INC.ILH2026-10-14
00810226442870ViveVIVE HEALTH LLCILH2026-10-12
00810226442887ViveVIVE HEALTH LLCILH2026-10-12
00810226442894ViveVIVE HEALTH LLCILH2026-10-12
00810226442900ViveVIVE HEALTH LLCILH2026-10-12
00810179882365CopperFitIdeavillage Products CorpILH2026-10-01
00810179882372CopperFitIdeavillage Products CorpILH2026-10-01
00810179882662CopperFitIdeavillage Products CorpILH2026-10-01
00810179882679CopperFitIdeavillage Products CorpILH2026-10-01
50609576700274Puritan®Puritan Medical ProductsILH2026-07-27
06974546525140TealmedNingbo Tealmed Emergency Products Co., Ltd.ILH2026-06-25
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475274313BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
B7685810200Buxton BioMedicalBUXTON BIOMEDICAL, INC.ILH2023-05-26
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08