FDA.reportPublic FDA data

Med Spec Cubital Tunnel Brace

Primary DI
00802357234462
Brand
Med Spec Cubital Tunnel Brace
Company
MEDICAL SPECIALTIES INCORPORATED
Model
223446
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802357234462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357234462008023572344628023572344620802357234462

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
003173028
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
00802357230846Tee Pee Thumb Protector2230842022-12-08
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14
00802357240067TRIPOD WRIST LACER II2240062025-01-14
00802357240111TRIPOD WRIST LACER II2240112025-01-14
00802357240128TRIPOD WRIST LACER II2240122025-01-14
00802357240142TRIPOD WRIST LACER II2240142025-01-14
00802357240159TRIPOD WRIST LACER II2240152025-01-14
00802357240166TRIPOD WRIST LACER II2240162025-01-14
00802357130702Prosplints1130702022-12-07
00802357130719Prosplints1130712022-12-07
00802357230815Tee Pee Thumb Protector2230812022-12-07
00802357230822Tee Pee Thumb Protector2230822022-12-07
00802357230853Tee Pee Thumb Protector2230852022-12-07
00802357230860Tee Pee Thumb Protector2230862022-12-07
00802357231805Suede Thumb Support2231802022-12-07
00802357231904Suede Thumb support2231902022-12-07
00802357232215Wrist Lacer2232212022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257215913MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215920MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215937MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215944MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215951MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00636257215968MEDIMEDI MANUFACTURING, INC.IQI2026-08-21
00190446660590PROCAREDJO, LLCIQI2026-07-31
00190446660606PROCAREDJO, LLCIQI2026-07-31
00190446660613PROCAREDJO, LLCIQI2026-07-31
00190446660620PROCAREDJO, LLCIQI2026-07-31
00190446660637PROCAREDJO, LLCIQI2026-07-31
00190446660644PROCAREDJO, LLCIQI2026-07-31
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20