FDA.reportPublic FDA data

Juzo SoftCompress

Primary DI
00640095288350
Brand
Juzo SoftCompress
Company
Julius Zorn, Inc.
Model
6846BAN10 BOX
Catalog number
28835
Device description
Bandage, Short Stretch, 10cm x 5m Box 10 , BOX
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
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00640095288350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095288350006400952883506400952883500640095288350

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, reusableA strip or roll of fabric or plastic material intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., treatment of lymphoedema, venous oedema and lipoedema, support injuries associated with minor trauma), and/or to secure hot/cold packs to the body to provide heat/cold therapy. It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. 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
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580676New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580911New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196691159MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745593MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745647MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745722MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
10080196789207MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-02
10080196823536MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-30
10080196692378MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10080196823543MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10097604110577Tronex International, Inc.TRONEX INTERNATIONAL, INC.FQM2025-05-05