FDA.reportPublic FDA data

MECRON Elbow Splint

Primary DI
10609271951966
Brand
MECRON Elbow Splint
Company
DARCO INTERNATIONAL, INC.
Model
OS030X04
Catalog number
OS030X04
Device description
XXS Black
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
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
04823097723395TM "Rehabilitimed" RP-6 XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723401TM "Rehabilitimed" RP-6 S ComfortREABILITIMED TOVIOY2025-05-17
04823097723418TM "Rehabilitimed" RP-6 XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723425TM "Rehabilitimed" RP-6 S ComfortREABILITIMED TOVIOY2025-05-17
04823097723432TM "Rehabilitimed" RP-6 M ComfortREABILITIMED TOVIOY2025-05-17
04823097723449TM "Rehabilitimed" RP-6 L ComfortREABILITIMED TOVIOY2025-05-17
04823097723456TM "Rehabilitimed" RP-6 XL ComfortREABILITIMED TOVIOY2025-05-17
04823097723494TM "Rehabilitimed" RP-6P XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723500TM "Rehabilitimed" RP-6P S ComfortREABILITIMED TOVIOY2025-05-17
04823097723517TM "Rehabilitimed" RP-6P XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723524TM "Rehabilitimed" RP-6P S ComfortREABILITIMED TOVIOY2025-05-17
04823097723531TM "Rehabilitimed" RP-6P M ComfortREABILITIMED TOVIOY2025-05-17
04823097723548TM "Rehabilitimed" RP-6P L ComfortREABILITIMED TOVIOY2025-05-17
04823097723555TM "Rehabilitimed" RP-6P XL ComfortREABILITIMED TOVIOY2025-05-17
04823097723562TM "Rehabilitimed" RP-6K-M UNI ComfortREABILITIMED TOVIOY2025-05-17
04823097723579TM "Rehabilitimed" RP-6K-M XXL ComfortREABILITIMED TOVIOY2025-05-17
04823097723586TM "Rehabilitimed" RP-6K-M1 UNIp-2 ComfortREABILITIMED TOVIOY2025-05-17
04823097723593TM "Rehabilitimed" RP-6K-M1 UNIp-1 ComfortREABILITIMED TOVIOY2025-05-17
04823097723609TM "Rehabilitimed" RP-6K-M1 UNIp-2 ComfortREABILITIMED TOVIOY2025-05-17
04823097723616TM "Rehabilitimed" RP-6K-M1 UNIp-1 ComfortREABILITIMED TOVIOY2025-05-17
04823097723623TM "Rehabilitimed" RP-6K-M1 UNI ComfortREABILITIMED TOVIOY2025-05-17
04823097723630TM "Rehabilitimed" RP-6K-M1 XXL ComfortREABILITIMED TOVIOY2025-05-17
04823097719176TM "Rehabilitimed" RP-6 XS ComfortREABILITIMED TOVIOY2025-05-04