FDA.reportPublic FDA data

ORTHOSIS HAND CONTRACTURE CARROT INFLATABLE KIT

Primary DI
00733657277739
Brand
ORTHOSIS HAND CONTRACTURE CARROT INFLATABLE KIT
Company
ALIMED, INC.
Model
51598
Catalog number
2970002260
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IODCOMPONENTS, EXERCISE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733657277739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657277739007336572777397336572777390733657277739

GMDN Terms#

Term, Definition table
TermDefinition
Hand orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags#

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733657221923WRST ELASTIC FRDM LONG XXSM/RT572829700035922022-12-01
00733657221930WRST ELASTIC FRDM LONG XXSM/LF572929700035932022-12-01
00733657221947WRST ELASTIC FRDM LONG RT/XSM573029700035942022-12-01
00733657221954WRST ELASTIC FRDM LONG LF/XSM573129700035952022-12-01
00733657221961WRIST ELASTIC FRDM LONG RT/SM573229700035962022-12-01
00733657221978WRIST ELASTIC FRDM LONG LF/SM573329700035972022-12-01
00733657221985WRIST ELASTIC FRDM LONG RT/MD573429700035982022-12-01
00733657221992WRIST ELASTIC FRDM LONG LF/MD573529700035992022-12-01
00733657222005WRIST ELASTIC FRDM LONG RT/LG573629700036002022-12-01
00733657222012WRIST ELASTIC FRDM LONG LF/LG573729700036012022-12-01
00733657222029WRIST ELASTIC FRDM LONG RT/XLG573829700036022022-12-01
00733657222036WRIST ELASTIC FRDM LONG LF/XLG573929700036032022-12-01
00733657222074WRIST ELASTIC FRDM SHORT RT/XSM576029700036062022-12-01
00733657222081WRIST ELASTIC FRDM SHORT LF/XSM576129700036072022-12-01
00733657222098WRIST ELASTIC FRDM SHORT RT/SM576229700036082022-12-01
00733657222104WRIST ELASTIC FRDM SHORT LF/SM576329700036092022-12-01
00733657222111WRIST ELASTIC FRDM SHORT RT/MD576429700036102022-12-01
00733657222128WRIST ELASTIC FRDM SHORT LF/MD576529700036112022-12-01
00733657222135WRIST ELASTIC FRDM SHORT RT/LG576629700036122022-12-01
00733657222142WRIST ELASTIC FRDM SHORT LF/LG576729700036132022-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810113576367ViveVIVE HEALTH LLCIOD2024-08-20
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10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
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G505MRUHB0Unloading Harness BariatricM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHS0Unloading HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
00840252911828Dig-o-meterTherafin CorporationIOD2023-07-06
00810041982353VIVEVIVE HEALTH LLCIOD2023-06-30
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07290019733003HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733836TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
07290019733843TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
072900197338503DTutor StationMEDITOUCH LTDIOD2023-06-21
072900197338673DTutorMEDITOUCH LTDIOD2023-06-21
07290019733874LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733881LegTutorMEDITOUCH LTDIOD2023-06-21