FDA.reportPublic FDA data

VELPEAU IMMOBILIZER/SLING LG

Primary DI
00610570190492
Brand
VELPEAU IMMOBILIZER/SLING LG
Company
Bird & Cronin, LLC
Model
08140084
Published
2022-08-30
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
00610570190492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570190492006105701904926105701904920610570190492

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, single-useA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a single-use 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
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00840536801081PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
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00840536823571PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823588PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823595PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823601PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823618PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823625PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823632PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823649PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823656PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823663PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823670PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823687PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823694PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536823700PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824165PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824172PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824189PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824196PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824202PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824219PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824226PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824233PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824240PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824257PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824264PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824271PediHipORTHOPEDIATRICS CORP.IQI2026-10-01
00840536824769PediHipORTHOPEDIATRICS CORP.IQI2026-10-01