FDA.reportPublic FDA data

Juzo Custom Compression Garments

Primary DI
00640095208860
Brand
Juzo Custom Compression Garments
Company
Julius Zorn, Inc.
Model
3021TH.MTM
Catalog number
20886
Device description
18-21 mmHg, Expert, Thorax, Custom
Published
2023-09-08
Public version status
Update
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
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00640095208860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095208860006400952088606400952088600640095208860

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure shirt/pantsA garment in the form of a vest, shirt, pants, leggings, or whole-body suit intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. It is a piece of clothing designed to be worn around the hips and/or shoulders, and is neither a strip/roll binder, limb sleeve, glove, nor sock. It is typically made of cotton or synthetic elastic material (e.g., Lycra); it does not include antimicrobial features. Absorbent pads may be used underneath the device. 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
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
00640095208976Juzo Custom Compression Garments3022SVTHSG.MTM208972023-09-08

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Primary DI, Brand, Company table
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00745129335106Envelo Arm Wrap Max Small Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long BeigeSIGVARIS INCMDR2026-07-22
00745129335120Envelo Arm Wrap Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335137Envelo Arm Wrap Medium Regular BeigeSIGVARIS INCMDR2026-07-22
00745129335144Envelo Arm Wrap Medium Long BeigeSIGVARIS INCMDR2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short BeigeSIGVARIS INCMDR2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular BeigeSIGVARIS INCMDR2026-07-22
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00745129334949Envelo Arm Wrap X-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129334956Envelo Arm Wrap X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334963Envelo Arm Wrap X-Large Long BlackSIGVARIS INCMDR2026-07-20
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00745129334987Envelo Arm Wrap Max X-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129334994Envelo Arm Wrap Max X-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335007Envelo Arm Wrap XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335014Envelo Arm Wrap XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335021Envelo Arm Wrap XX-Large Long BlackSIGVARIS INCMDR2026-07-20
00745129335038Envelo Arm Wrap Max XX-Large Short BlackSIGVARIS INCMDR2026-07-20
00745129335045Envelo Arm Wrap Max XX-Large Regular BlackSIGVARIS INCMDR2026-07-20
00745129335052Envelo Arm Wrap Max XX-Large Long BlackSIGVARIS INCMDR2026-07-20
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