FDA.report

Juzo Ortho Supports

Primary DI
00640095028352
Brand
Juzo Ortho Supports
Company
Julius Zorn, Inc.
Model
3512AB 1
Catalog number
02835
Device description
30-40 mmHg, Ankle Support , 1
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
IOYSUPPORT, ARM

Product Code Classifications

CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00640095028352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095028352006400950283526400950283520640095028352

GMDN Terms

TermDefinition
Tubular support bandage, non-latex, reusableA tubular, elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, 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

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