FDA.report

Juzo Dynamic Xtra

Primary DI
00640095200260
Brand
Juzo Dynamic Xtra
Company
Julius Zorn, Inc.
Model
3572FGESB10 II
Catalog number
20026
Device description
30-40 mmHg, Xtra, AK Shrinker, 14"/35 cm, Silicone, Black, II
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IPMCOVER, LIMB

Product Code Classifications

CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00640095200260PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00640095200260140064009520026006400952002600640095200260Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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

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
20809160489885Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-08-01
20809160489465Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-07-31
08717127934409Arion Easy-Slide Arion Holding B.V.IPM2025-02-03
08717127934416Arion MagnideArion Holding B.V.IPM2025-02-03
08717127934423Arion Sim-Slide Arion Holding B.V.IPM2025-02-03
08717127934430Arion Easy-OffArion Holding B.V.IPM2025-02-03
08717127934447Arion Easy-Slide ArmArion Holding B.V.IPM2025-02-03
08717127934454Arion Proth-ProArion Holding B.V.IPM2025-02-03
08717127930111Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930401Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930432Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930463Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930494Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930555Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930586Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930616Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930647Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930678Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930708Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930739Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930760Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930791Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930821Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930852Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930883Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930913Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930944Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930975Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931002Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931040Arion SlideXArion Holding B.V.IPM2025-01-13