FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756562003
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
9262-00
Catalog number
9262-00
Device description
ARM PROTECTORS
Published
2021-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, skin pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756562008PackageGS112In Commercial Distribution
00749756562003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975656200850749756562008
00749756562003007497565620037497565620030749756562003

GMDN Terms#

Term, Definition table
TermDefinition
Arm friction/impact protectorA device designed to be worn over some length of the arm (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb and its skin from friction and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the arm, or has a tubular sleeve design; it is not dedicated to the elbow. It is typically used by persons who have thinning skin or skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.

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
Manufacturing date on label
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

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Primary DI, Brand, Company table
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07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
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00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
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00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
00816299013337HoverMatt PROSWedgeHovertech InternationalFMP2026-07-06
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05