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Juzo Soft Seamless

FDA UDI

Class I (US FDA UDI)

by Julius Zorn, Inc.

Identity

Trade Name
Juzo Soft Seamless FDA UDI
Generic Name
Compression/pressure glove FDA UDI
Device Name
20-30 mmHg, Soft, Seamless Gauntlet, Right, Beige, L FDA UDI
Model / Reference
2001ACRI14 L FDA UDI
Description
20-30 mmHg, Soft, Seamless Gauntlet, Right, Beige, L FDA UDI

Identifiers

Catalog Number
31397 FDA UDI
Primary DI / UDI-DI
00640095313977 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

Juzo Soft Seamless by Julius Zorn, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 c1b2e31b-65b3-4a21-baf1-ad6a0c1516fa 35 fields · synced Jun 6, 2026