FDA.reportPublic FDA data

Juzo Soft

Primary DI
00640095167891
Brand
Juzo Soft
Company
Julius Zorn, Inc.
Model
2082ATSH14 II
Catalog number
16789
Device description
30-40 mmHg, Soft, Elastic Panty, OT, Short, Beige, 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
FQLSTOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00640095167891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095167891006400951678916400951678910640095167891

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use 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
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204001Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4204011Compression StockingGottfried Medical, Inc.FQL2026-06-04