FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756157582
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
AD2004-FM
Catalog number
AD2004-FM
Device description
Sock Aid
Published
2021-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILDADAPTOR, DRESSING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILDAdaptor, DressingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756157582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756157582007497561575827497561575820749756157582

GMDN Terms#

Term, Definition table
TermDefinition
Assistive dressing/undressing hook/stickA device typically in the form of a hook with a handle, or a long stick with a handle and a hook at the distal end, designed to be used by a person with a disability to hook, fix, or grasp a garment to manoeuvre and adjust it while dressing or undressing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818323022797ViveVIVE HEALTH LLCILD2026-05-11
00818323025279ViveVIVE HEALTH LLCILD2026-05-11
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05050962023048LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962057791SOXONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962080065LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110168REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110175REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146372REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146389REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156210REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156227REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156234REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156241REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156258REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156265SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962161269SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962164192EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171152HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171169HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177895HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177918HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962203983ARTHRI GRIPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962355002EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
00023601042248CarexDrive Devilbiss HealthcareILD2024-01-08
00023601042255CarexDrive Devilbiss HealthcareILD2023-09-29
30023601042256CarexCOMPASS HEALTH BRANDS CORP.ILD2023-09-29
00840252902925Cushion GripTherafin CorporationILD2023-07-06
00840252902949Cushion GripTherafin CorporationILD2023-07-06
00840252902963Cushion GripTherafin CorporationILD2023-07-06