FDA.reportPublic FDA data

Juzo Soft

Primary DI
00640095230304
Brand
Juzo Soft
Company
Julius Zorn, Inc.
Model
2002CGLSB00 II
Catalog number
23030
Device description
30-40 mmHg, Soft, Sleeve, Long, Silicone, Trend, II
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IOYSUPPORT, ARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00640095230304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095230304006400952303046400952303040640095230304

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)222-4999customercare@juzousa.com

Regulatory Flags#

DUNS number
123197535
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00640095132424Juzo Custom Compression Garments3021KT.MTM132422023-09-08
00640095132431Juzo Custom Compression Garments3021KTHL.MTM132432023-09-08
00640095132448Juzo Custom Compression Garments3022KT.MTM132442023-09-08
00640095132455Juzo Custom Compression Garments3022KTHL.MTM132452023-09-08
00640095132462Juzo Custom Compression Garments3023KT.MTM132462023-09-08
00640095132509Juzo Custom Compression Garments3021COKT.MTM132502023-09-08
00640095132516Juzo Custom Compression Garments3022COKT.MTM132512023-09-08
00640095136255Juzo Custom Compression Garments3021SVKT.MTM136252023-09-08
00640095136262Juzo Custom Compression Garments3022SVKT.MTM136262023-09-08
00640095208860Juzo Custom Compression Garments3021TH.MTM208862023-09-08
00640095208877Juzo Custom Compression Garments3022TH.MTM208872023-09-08
00640095208884Juzo Custom Compression Garments3021THSG.MTM208882023-09-08
00640095208891Juzo Custom Compression Garments3022THSG.MTM208892023-09-08
00640095208907Juzo Custom Compression Garments3021TO.MTM208902023-09-08
00640095208914Juzo Custom Compression Garments3022TO.MTM208912023-09-08
00640095208921Juzo Custom Compression Garments3021TOSG.MTM208922023-09-08
00640095208938Juzo Custom Compression Garments3022TOSG.MTM208932023-09-08
00640095208945Juzo Custom Compression Garments3021SVTH.MTM208942023-09-08
00640095208952Juzo Custom Compression Garments3022SVTH.MTM208952023-09-08
00640095208969Juzo Custom Compression Garments3021SVTHSG.MTM208962023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974500613555Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
06974500613593Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.IOY2025-10-17
00636257207710MEDIMEDI MANUFACTURING, INC.IOY2025-09-26
00636257204924MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204931MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204948MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204955MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
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