FDA.report

Juzo SoftCompress

Primary DI
00640095288183
Brand
Juzo SoftCompress
Company
Julius Zorn, Inc.
Model
6839GEF 2
Catalog number
28818
Device description
SoftCompress Pad, Genital, Female , 2
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IQODEVICE, PROSTHESIS ALIGNMENT

Product Code Classifications

CodeDeviceSpecialtyClass
IQODevice, Prosthesis AlignmentPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00640095288183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095288183006400952881836400952881830640095288183

GMDN Terms

TermDefinition
General-purpose medical foam padding, reusableA roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)222-4999customercare@juzousa.com

Regulatory Flags

DUNS number
123197535
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00640095103110Juzo Basic4412ADFFSH14 I103112023-09-08
00640095103127Juzo Basic4412ADFFSH14 II103122023-09-08
00640095103134Juzo Basic4412ADFFSH14 III103132023-09-08
00640095103141Juzo Basic4412ADFFSH14 IV103142023-09-08
00640095103172Juzo Custom Compression Garments3052SVCG.MTM103172023-09-08
00640095103189Juzo Custom Compression Garments3053SVCG.MTM103182023-09-08
00640095103295Juzo Custom Compression Garments3052SVAG.MTM103292023-09-08
00640095103301Juzo Custom Compression Garments3053SVAG.MTM103302023-09-08
00640095103325Juzo Custom Compression Garments3051SVACFS.MTM103322023-09-08
00640095103356Juzo Custom Compression Garments3023COBT.MTM103352023-09-08
00640095103530Juzo Custom Compression Garments3052SVFP.MTM103532023-09-08
00640095103547Juzo Custom Compression Garments2001AG.MTM103542023-09-08
00640095103585Juzo Custom Compression Garments2002AD.MTM103582023-09-08
00640095103608Juzo Custom Compression Garments2002AG.MTM103602023-09-08
00640095103677Juzo Custom Compression Garments3561CF.MTM103672023-09-08
00640095103684Juzo Custom Compression Garments3562CF.MTM103682023-09-08
00640095103691Juzo Dynamic3511AGSBSH I103692023-09-08
00640095103707Juzo Dynamic3511AGSBSH II103702023-09-08
00640095103714Juzo Dynamic3511AGSBSH III103712023-09-08
00640095103721Juzo Dynamic3511AGSBSH IV103722023-09-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841747186912Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00841747186929Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00195411036455Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036622Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036790Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036813Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411108602Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192298Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192304Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192311Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192328Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192342Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192359Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192366Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192373Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192380Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192397Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192403Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192410Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192427Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192434Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214440Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214457Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269150Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269167Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269174Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269181Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269198Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269204Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269211Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26