FDA.reportPublic FDA data

NON FRANCHISE

Primary DI
00190446704911
Brand
NON FRANCHISE
Company
DJO, LLC
Model
88-578000727034
Device description
Cryotherm Shoulder Wrap w/4 Gels UNIV
Published
2023-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IQJSPLINT, CLAVICLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQJSplint, ClaviclePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446704911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446704911001904467049111904467049110190446704911

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-joint arm orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the arm. It is designed to support the elbow and at least one additional joint (i.e., shoulder and/or wrist) and may additionally support the hand. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

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Primary DI, Brand, Company table
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04823097717561"TM ""Rehabilitimed"" OT-2 Sp Comfort"REABILITIMED TOVIQJ2025-05-05
04823097717578"TM ""Rehabilitimed"" OT-2 UNIp Comfort"REABILITIMED TOVIQJ2025-05-05
04823097717585"TM ""Rehabilitimed"" OT-2 UNI Comfort"REABILITIMED TOVIQJ2025-05-05
04823097717592"TM ""Rehabilitimed"" OT-2 XXL Comfort"REABILITIMED TOVIQJ2025-05-05
00810060888155Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888162Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888179Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888186Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888193Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888254Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888261Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888278Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888285Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888292Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888353Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888360Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888377Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888384Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888391Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060887554Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887561Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887578Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887585Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887899Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887905Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887912Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00810060887929Rhino MD ORTHOPAEDICS, INC.IQJ2023-12-20
00190446704881NON FRANCHISEDJO, LLCIQJ2023-03-02
00190446704904NON FRANCHISEDJO, LLCIQJ2023-03-02
00609271950016MECRON Shoulder ClassicDarco (Europe) GmbHIQJ2023-02-08