FDA.reportPublic FDA data

Juzo Suspension Sleeve

Primary DI
00640095025153
Brand
Juzo Suspension Sleeve
Company
Julius Zorn, Inc.
Model
3232DF 6
Catalog number
02515
Device description
"Suspension Sleeve, 12"" / 30 cm , 6"
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
00640095025153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095025153006400950251536400950251530640095025153

GMDN Terms#

Term, Definition table
TermDefinition
Tubular support bandage, non-latex, reusableA tubular, elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, 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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