FDA.reportPublic FDA data

MECRON Elbow Splint

Primary DI
00609271951969
Brand
MECRON Elbow Splint
Company
Darco (Europe) GmbH
Model
OS030X04
Catalog number
OS030X04
Device description
XXS Black
Published
2023-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IOYSUPPORT, ARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271951966PackageGS112In Commercial Distribution
00609271951969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927195196610609271951966
00609271951969006092719519696092719519690609271951969

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisA prefabricated (non-customized) externally applied and wearable 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.

Regulatory Flags#

DUNS number
343551081
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609271950238MECRON Knee Flexion L:400mm, OS:430mm, US:300mmOH400104OH4001042023-02-08
00609271950269MECRON Knee Flexion L:400mm, OS:480mm, US:350mmOH400204OH4002042023-02-08
00609271950290MECRON Knee Flexion L:400mm, OS:530mm, US:400mmOH400304OH4003042023-02-08
00609271950320MECRON Knee Flexion L:500mm, OS:440mm, US:230mmOH500104OH5001042023-02-08
00609271950351MECRON Knee Flexion L:500mm, OS:490mm, US:280mmOH500204OH5002042023-02-08
00609271950382MECRON Knee Flexion L:500mm, OS:540mm, US:330mmOH500304OH5003042023-02-08
00609271950412MECRON Knee Flexion L:500mm, OS:590mm, US:380mmOH500404OH5004042023-02-08
00609271950443MECRON Knee Flexion L:600mm, OS:450mm, US:220mmOH600104OH6001042023-02-08
00609271950474MECRON Knee Flexion L:600mm, OS:500mm, US:270mmOH600204OH6002042023-02-08
00609271950504MECRON Knee Flexion L:600mm, OS:550mm, US:320mmOH600304OH6003042023-02-08
00609271950535MECRON Knee Flexion L:600mm, OS:600mm, US:350mmOH600404OH6004042023-02-08
00609271950559MECRON Knee 3-partOH655124OH6551242023-02-08
00609271950573MECRON Knee 3-partOH655324OH6553242023-02-08
00609271950597MECRON Knee 3-partOH655524OH6555242023-02-08
00609271950917MECRON Knee PediatricOS302001OS3020012023-02-08
00609271950924MECRON Knee PediatricOS303001OS3030012023-02-08
00609271950931MECRON Knee PediatricOS304001OS3040012023-02-08
00609271950962MECRON Knee Straight L:400mm, OS:430mm, US:300mmOS400104OS4001042023-02-08
00609271950993MECRON Knee Straight L:400mm, OS:480mm, US:350mmOS400204OS4002042023-02-08
00609271951020MECRON Knee Straight L:400mm, OS:530mm, US:400mmOS400304OS4003042023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974500613555Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
06974500613593Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.IOY2025-10-17
00636257207710MEDIMEDI MANUFACTURING, INC.IOY2025-09-26
00636257204924MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204931MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204948MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204955MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
04823097723395"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723401"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723418"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723425"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723432"TM ""Rehabilitimed"" RP-6 M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723449"TM ""Rehabilitimed"" RP-6 L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723456"TM ""Rehabilitimed"" RP-6 XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723494"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723500"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723517"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723524"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723531"TM ""Rehabilitimed"" RP-6P M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723548"TM ""Rehabilitimed"" RP-6P L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723555"TM ""Rehabilitimed"" RP-6P XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723562"TM ""Rehabilitimed"" RP-6K-M UNI Comfort"REABILITIMED TOVIOY2025-05-17
04823097723579"TM ""Rehabilitimed"" RP-6K-M XXL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723586"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723593"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723609"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723616"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17