FDA.reportPublic FDA data

"HIP SPICA ELASTIC 50-58"" 2XL"

Primary DI
00610570070640
Brand
"HIP SPICA ELASTIC 50-58"" 2XL"
Company
Bird & Cronin, LLC
Model
08148106
Published
2022-08-20
Public version status
Update
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
00610570070640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570070640006105700706406105700706400610570070640

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure shirt/pantsA garment in the form of a vest, shirt, pants, leggings, or whole-body suit intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. It is a piece of clothing designed to be worn around the hips and/or shoulders, and is neither a strip/roll binder, limb sleeve, glove, nor sock. It is typically made of cotton or synthetic elastic material (e.g., Lycra); it does not include antimicrobial features. Absorbent pads may be used underneath the device. 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
00840194499194Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499200Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499217Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499224Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499231Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499248Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499255Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499262Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499279Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00645517899350TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899367TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899374TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899381TrulifeTRULIFE LIMITEDIQI2026-02-17
00860014768606QuickBraceINNOMOTIVE L.L.CIQI2026-02-11
00690079011306Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079011313Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012303Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012310Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00810113682969"ManaEZ Single Panel Knee Immobilizer 18"""Manamed, Inc.IQI2025-11-25
00810113682976"ManaEZ Single Panel Knee Immobilizer 20"""Manamed, Inc.IQI2025-11-25
00810113682983"ManaEZ Single Panel Knee Immobilizer 24"""Manamed, Inc.IQI2025-11-25
00810113682990"ManaEZ 3 Panel Knee Immobilizer 18"""Manamed, Inc.IQI2025-11-25
00810113683003"ManaEZ 3 Panel Knee Immobilizer 20"""Manamed, Inc.IQI2025-11-25
00810113683010"ManaEZ 3 Panel Knee Immobilizer 24"""Manamed, Inc.IQI2025-11-25
00810113683294"ManaEZ 3 Panel Knee Immobilizer 16"""Manamed, Inc.IQI2025-11-25
00810079192144Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079192151Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079191918Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079191925Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079192311Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17