FDA.reportPublic FDA data

Elbow Brace Elastic Support Black Small

Primary DI
00610570191505
Brand
Elbow Brace Elastic Support Black Small
Company
Bird & Cronin, LLC
Model
08140134
Published
2023-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00610570191505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570191505006105701915056105701915050610570191505

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
045975349
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610570187386BULB HOLDER081482202022-10-31
00610570176519CHAS CATH-MATE STRAP081482002022-08-30
00610570176526CATH-MATE II CATHETER STRAP081482142022-08-30
00610570176786CHAS II CATH-MATE STRAP081482012022-08-30
00610570187379"CATH-MATE II X-LONG STRAP 28"""081482132022-08-30
50610570189552PRODY DRAINAGE BULB HOLDER II081477202022-08-30
00610570142309CHAS CATH-MATE STRAP 2/PK500082002022-08-20
00610570145584BULB HOLDER KIT081482212022-08-20
00610570157839"9"" ABD W/DRAIN HLDR UP TO 45"""081482262022-08-20
00610570157846"9"" ABD W/DRAIN HLDR 46-62"""081482272022-08-20
00610570157853"9"" ABD W/DRAIN HLDR 55-72"""081482282022-08-20
00610570165285"6"" ABD W/DRAIN HLDR UP TO 60"""081482302022-08-20
00610570165889"12"" ABD W/DRAIN HLDR UP TO 45"""081482362022-08-20
00610570165902"12"" ABD W/DRAIN HLDR 46-62"""081482372022-08-20
00610570165919"12"" ABD W/DRAIN HLDR 55-72"""081482382022-08-20
00610570165926"12"" ABD W/DRAIN HLDR 72-96"""081482392022-08-20
00610570189564PRODY DRAINAGE BULB HOLDER II KIT081477212022-08-20
00610570189571"PRODY 9"" ABD II W/DRAIN HLDR UP TO 45"""081477262022-08-20
00610570189588"PRODY 9"" ABD II W/DRAIN HLDR 46-62"""081477272022-08-20
00610570189595"PRODY 9"" ABD II W/DRAIN HLDR 55-72"""081477282022-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221358MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221365MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221372MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221389MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221396MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221402MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221419MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221426MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221433MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221440MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221457MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221464MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221471MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221488MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221495MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221501MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221563MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221570MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221587MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221594MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221600MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221617MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221624MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221631MEDIMEDI MANUFACTURING, INC.IQI2026-07-20