FDA.reportPublic FDA data

Juzo Compression Wrap

Primary DI
00640095287681
Brand
Juzo Compression Wrap
Company
Julius Zorn, Inc.
Model
6000FGR M
Catalog number
28768
Device description
Wrap, Thigh, Regular , M
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
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00640095287681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095287681006400952876816400952876810640095287681

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
08300496073246SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
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08300496073284SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073291SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073307SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073314SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073321SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073338SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073345SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
08300496073352SOLIDEACALZIFICIO PINELLI SRLMDR2026-05-15
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00636257043110MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043127MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043134MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043141MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043158MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043165MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043172MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043189MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043196MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043202MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043219MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047507MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047514MEDIMEDI MANUFACTURING, INC.MDR2026-01-23