FDA.report

Juzo Soft Seamless

Primary DI
00640095309796
Brand
Juzo Soft Seamless
Company
Julius Zorn, Inc.
Model
2000ACLE10 S
Catalog number
30979
Device description
15-20 mmHg, Soft, Seamless Gauntlet, Left, Black, S
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
00640095309796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00640095309796006400953097966400953097960640095309796

GMDN Terms

TermDefinition
Compression/pressure gloveA device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. 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

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