FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756013017
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
6003-01
Catalog number
6003-01
Device description
ELBOW BRACE
Published
2021-07-29
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
IRDJOINT, ELBOW, EXTERNAL LIMB COMPONENT, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRDJoint, Elbow, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756013017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756013017007497560130177497560130170749756013017

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisAn externally applied orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.

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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179880729CopperfitIdeavillage Products CorpIRD2025-02-04
00810179880309CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880316CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880323CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880330CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880347CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880354 CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880361CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880378CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880385CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880392CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880408 CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880415CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880422CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880446CopperfitIdeavillage Products CorpIRD2024-11-18
00810179880453CopperfitIdeavillage Products CorpIRD2024-11-18
05055348200792Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348201218ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348227997Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348247742Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348247780ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348247797ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348248572Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348252920Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348262127ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348262134ElbowHUGH STEEPER LIMITEDIRD2023-08-02
05055348262257Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348262288Control and Suspension SystemsHUGH STEEPER LIMITEDIRD2023-08-02
05055348201058ElbowHUGH STEEPER LIMITEDIRD2023-08-01
05055348201065ElbowHUGH STEEPER LIMITEDIRD2023-08-01