FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756796552
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
406S10
Catalog number
406S10
Device description
CLAVICLE STRAP
Published
2023-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IQJSPLINT, CLAVICLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQJSplint, ClaviclePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756796557PackageGS16In Commercial Distribution
00749756796552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975679655750749756796557
00749756796552007497567965527497567965520749756796552

GMDN Terms#

Term, Definition table
TermDefinition
Clavicle orthosisA prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It incorporates padded straps that loop over each shoulder, under each arm, and around the back (e.g., figure-of-eight harness). This device may also be used to improve the patient's posture. This is a reusable device.

Regulatory Flags#

DUNS number
096372255
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
04823097717561"TM ""Rehabilitimed"" OT-2 Sp Comfort"REABILITIMED TOVIQJ2025-05-05
04823097717578"TM ""Rehabilitimed"" OT-2 UNIp Comfort"REABILITIMED TOVIQJ2025-05-05
04823097717585"TM ""Rehabilitimed"" OT-2 UNI Comfort"REABILITIMED TOVIQJ2025-05-05
04823097717592"TM ""Rehabilitimed"" OT-2 XXL Comfort"REABILITIMED TOVIQJ2025-05-05
00810060888155Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888162Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888179Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888186Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888193Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888254Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888261Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888278Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888285Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888292Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888353Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888360Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888377Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888384Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888391Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060887554Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887561Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887578Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887585Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887899Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887905Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887912Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887929Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00190446704881NON FRANCHISEDJO, LLCIQJ2023-03-02
00190446704904NON FRANCHISEDJO, LLCIQJ2023-03-02
00190446704911NON FRANCHISEDJO, LLCIQJ2023-03-02