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Juzo Soft

FDA UDI

Class I (US FDA UDI)

by Julius Zorn, Inc.

Identity

Trade Name
Juzo Soft FDA UDI
Generic Name
Compression/pressure glove FDA UDI
Device Name
20-30 mmHg, Soft, Sleeve, Regular, Silicone, Black, V FDA UDI
Model / Reference
2001CGRSB10 V FDA UDI
Description
20-30 mmHg, Soft, Sleeve, Regular, Silicone, Black, V FDA UDI

Identifiers

Catalog Number
11395 FDA UDI
Primary DI / UDI-DI
00640095113959 FDA UDI
FDA Product Code
IOY FDA UDI
GMDN Term
Compression/pressure glove FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Compression/pressure glove

The Juzo Soft compression/pressure glove is a medical device designed to provide gentle, non-invasive support and compression to individuals with arthritis, injuries, or lymphedema. Made from soft, silicone material, it features an adjustable sleeve that ensures a secure fit. The device has undergone extensive testing for safety and efficacy, and its compliance with FDA regulations has been verified.

Similar devices

Also classified as Compression/pressure glove.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Julius Zorn, Inc.

Sources (1)

  • FDA UDI 311bbb50-16c6-4ca4-87be-e62c63587162 35 fields · synced Jul 14, 2026