NON FRANCHISE

Primary DI
00190446704881
Brand
NON FRANCHISE
Company
DJO, LLC
Model
88-578000727030
Device description
Cryotherm Shoulder Wrap No 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
OTC
false
Sterile
false
Single use
false

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
00190446704881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446704881001904467048811904467048810190446704881

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

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04823097717585TM "Rehabilitimed" OT-2 UNI ComfortREABILITIMED TOVIQJ2025-05-05
04823097717592TM "Rehabilitimed" OT-2 XXL ComfortREABILITIMED TOVIQJ2025-05-05
00810060888155Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
00810060888162Rhino MD ORTHOPAEDICS, INC.IQJ2024-01-02
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00190446704904NON FRANCHISEDJO, LLCIQJ2023-03-02
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10609271950013MECRON Shoulder ClassicDARCO INTERNATIONAL, INC.IQJ2023-02-08