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
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
00749756401753DeRoyal23-800P23-800P2026-09-18
00749756401760DeRoyal23-806P23-806P2026-09-18
00749756401777DeRoyal23-805P23-805P2026-09-18
00749756401784DeRoyal23-801P23-801P2026-09-18
00749756401920DeRoyal46-LT5S-05B46-LT5S-05B2026-09-18
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22

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