FDA.reportPublic FDA data

"COMFOR RIB BELT 24-60"" CONTOUR"

Primary DI
00610570006281
Brand
"COMFOR RIB BELT 24-60"" CONTOUR"
Company
Bird & Cronin, LLC
Model
08141389
Published
2022-08-20
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
IPXOrthosis, Rib Fracture, Soft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPXOrthosis, Rib Fracture, SoftPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00610570006281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570006281006105700062816105700062810610570006281

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

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
00190446660576PROCAREDJO, LLCIPX2025-07-23
04823097721650"TM ""Rehabilitimed"" BR-2 S Comfort"REABILITIMED TOVIPX2025-06-19
04823097721667"TM ""Rehabilitimed"" BR-2 M Comfort"REABILITIMED TOVIPX2025-06-19
04823097721674"TM ""Rehabilitimed"" BR-2 L Comfort"REABILITIMED TOVIPX2025-06-19
04823097721681"TM ""Rehabilitimed"" BR-2 XL Comfort"REABILITIMED TOVIPX2025-06-19
04823097721698"TM ""Rehabilitimed"" BR-2 XXL Comfort"REABILITIMED TOVIPX2025-06-19
04823097723678"TM ""Rehabilitimed"" BR-1 S Comfort"REABILITIMED TOVIPX2025-06-19
04823097723685"TM ""Rehabilitimed"" BR-1 M Comfort"REABILITIMED TOVIPX2025-06-19
04823097723692"TM ""Rehabilitimed"" BR-1 L Comfort"REABILITIMED TOVIPX2025-06-19
04823097723708"TM ""Rehabilitimed"" BR-1 XL Comfort"REABILITIMED TOVIPX2025-06-19
04823097723715"TM ""Rehabilitimed"" BR-1 XXL Comfort"REABILITIMED TOVIPX2025-06-19
04823097706886"TM ""Rehabilitimed"" BR-2 S"REABILITIMED TOVIPX2025-05-04
04823097706893"TM ""Rehabilitimed"" BR-2 M"REABILITIMED TOVIPX2025-05-04
04823097706909"TM ""Rehabilitimed"" BR-2 L"REABILITIMED TOVIPX2025-05-04
04823097706916"TM ""Rehabilitimed"" BR-2 XL"REABILITIMED TOVIPX2025-05-04
04823097706923"TM ""Rehabilitimed"" BR-2 XXL"REABILITIMED TOVIPX2025-05-04
04823097706930"TM ""Rehabilitimed"" BR-2 XXXL"REABILITIMED TOVIPX2025-05-04
04823097706947"TM ""Rehabilitimed"" BR-2 S"REABILITIMED TOVIPX2025-05-04
04823097706954"TM ""Rehabilitimed"" BR-2 M"REABILITIMED TOVIPX2025-05-04
04823097706961"TM ""Rehabilitimed"" BR-2 L"REABILITIMED TOVIPX2025-05-04
04823097706978"TM ""Rehabilitimed"" BR-2 XL"REABILITIMED TOVIPX2025-05-04
04823097706985"TM ""Rehabilitimed"" BR-2 XXL"REABILITIMED TOVIPX2025-05-04
04823097706992"TM ""Rehabilitimed"" BR-2 XXXL"REABILITIMED TOVIPX2025-05-04
00609271950108MECRON Belt B: 22 cm, U: 66-86 cmDarco (Europe) GmbHIPX2023-02-14
00609271950115MECRON Belt B: 22 cm, U: 84-110 cmDarco (Europe) GmbHIPX2023-02-14
00609271950122MECRON Belt B: 22 cm, U: 105-127 cmDarco (Europe) GmbHIPX2023-02-14
00609271950139MECRON Belt B: 22 cm, U: 130-157 cmDarco (Europe) GmbHIPX2023-02-14
00609271950146MECRON Belt B: 29 cm, U: 66-86 cmDarco (Europe) GmbHIPX2023-02-14
00609271950153MECRON Belt B: 29 cm, U: 84-110 cmDarco (Europe) GmbHIPX2023-02-14
00609271950160MECRON Belt B: 29 cm, U: 105-127 cmDarco (Europe) GmbHIPX2023-02-14