FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756151689
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
AD9000-HK
Catalog number
AD9000-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
00749756151689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756151689007497561516897497561516890749756151689

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
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
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018480895Primo PassiPrimo Passi LLCILW2026-09-19
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
00749756157469DeRoyalDEROYAL INDUSTRIES, INC.ILW2021-08-03
00749756163569DeRoyalDEROYAL 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