FDA.reportPublic FDA data

Elbow Support

Primary DI
16974500613552
Brand
Elbow Support
Company
GCMEDICA ENTERPRISE LTD.(WUXI)
Model
JP05C01
Device description
Resuable and Adjustable Elbow Support Matrials: Nylon, Neoprene Size: One Size,fits left and right Elbow
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
16974500613552PackageGS112In Commercial Distribution
06974500613555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697450061355216974500613552
06974500613555069745006135556974500613555

GMDN Terms#

Term, Definition table
TermDefinition
Elbow immobilizerA non-rigid external device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560122957
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
06974500612718Rigid Uterine Aspiration CuretteGC7049A07AU012026-05-18
06974500612725Rigid Uterine Aspiration CuretteGC7049A08AU012026-05-18
06974500612732Rigid Uterine Aspiration CuretteGC7049A09AU012026-05-18
06974500612749Rigid Uterine Aspiration CuretteGC7049A10AU012026-05-18
06974500612756Rigid Uterine Aspiration CuretteGC7049A11AU012026-05-18
06974500612763Rigid Uterine Aspiration CuretteGC7049A12AU012026-05-18
06974500612770Rigid Uterine Aspiration CuretteGC7049A14AU012026-05-18
06974500612787Rigid Uterine Aspiration CuretteGC7049A16AU012026-05-18
06974500612794Rigid Uterine Aspiration CuretteGC7049D14AU012026-05-18
06974500612824Rigid Uterine Aspiration CuretteGC7049B07BU012026-05-18
06974500612831Rigid Uterine Aspiration CuretteGC7049B08BU012026-05-18
06974500612848Rigid Uterine Aspiration CuretteGC7049B09BU012026-05-18
06974500612855Rigid Uterine Aspiration CuretteGC7049B10BU012026-05-18
06974500612862Rigid Uterine Aspiration CuretteGC7049B11BU012026-05-18
06974500612879Rigid Uterine Aspiration CuretteGC7049B12BU012026-05-18
06974500612886Rigid Uterine Aspiration CuretteGC7049B14BU012026-05-18
06974500612893Rigid Uterine Aspiration CuretteGC7049B16BU012026-05-18
06974500612909Rigid Uterine Aspiration CuretteGC7049E14BU012026-05-18
06974500613333Flexible Uterine Aspiration CuretteGC7049C04AU012026-05-18
06974500613340Flexible Uterine Aspiration CuretteGC7049C05AU012026-05-18

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
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
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