FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756747672
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
10-1367
Catalog number
10-1367
Device description
Child ER Wrist Brace
Published
2021-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756747672PackageGS1200In Commercial Distribution
00749756747677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975674767250749756747672
00749756747677007497567476777497567476770749756747677

GMDN Terms#

Term, Definition table
TermDefinition
Wrist orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the wrist. 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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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00636257213391MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
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00645517899329TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899336TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899343TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899398TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899404TrulifeTRULIFE LIMITEDIQI2026-04-22
00810075281620BoneFoamBONE FOAM, INC.IQI2025-08-15
10841156111298ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
10841156111304ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
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00810079190171Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
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00810079191727Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191734Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191741Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10