FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756163569
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
AD9001-HK
Catalog number
AD9001-HK
Device description
HIP KIT
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
ILWADAPTOR, GROOMING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILWAdaptor, GroomingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756163569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756163569007497561635697497561635690749756163569

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
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840252903137Nail CareTherafin CorporationILW2023-07-10
06975463630016CILOYUYAO RIKE ELECTRIC APPLIANCE CO., LTD.ILW2023-03-30
05708590380988MATRIX M Pressalit A/SILW2023-01-26
05708590381008MATRIX MPressalit A/SILW2023-01-26
07320450124501Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124518Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124525Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124532Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124549Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124556Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124563Etac Supply Center ABEtac Supply Center ABILW2022-12-07
07320450124570Etac Supply Center ABEtac Supply Center ABILW2022-12-07
00749756151689DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
00749756157469DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
00749756163637DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
05708590309385PLUSPressalit A/SILW2020-06-08
05708590309408PLUSPressalit A/SILW2020-06-08
05708590309415PLUSPressalit A/SILW2020-06-08
05708590309446PLUSPressalit A/SILW2020-06-08
05708590316109PLUSPressalit A/SILW2020-06-08
05708590316123PLUSPressalit A/SILW2020-06-08
05708590316161PLUSPressalit A/SILW2020-06-08
05708590316185PLUSPressalit A/SILW2020-06-08
05708590349688MATRIX M Pressalit A/SILW2020-06-08
05708590365565MATRIX MPressalit A/SILW2020-06-08
05708590367453MATRIX MPressalit A/SILW2020-06-08