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
00749756402316DeRoyalNP-6006ULNP-6006UL2026-10-16
00749756402323DeRoyalNP-6007ULNP-6007UL2026-10-16
00749756402330DeRoyalNP-6008ULNP-6008UL2026-10-16
00749756402347DeRoyalNP-0080ULNP-0080UL2026-10-16
00749756402354DeRoyalNP-6014ULNP-6014UL2026-10-16
00749756402361DeRoyalNP-6015ULNP-6015UL2026-10-16
00749756402378DeRoyalNP-6016ULNP-6016UL2026-10-16
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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