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Juzo Soft Seamless 2001ACFSLE57 XL

by Julius Zorn, Inc.

Juzo Soft Seamless 2001ACFSLE57 XL (31448) is a Class I device made by Julius Zorn, Inc., listed in FDA GUDID since 8 Sep 2023 (UDI-DI 00640095314486), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00640095314486 UDI-DI Date8 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Juzo Soft Seamless
Generic name
Compression/pressure glove
Model / Ref / Catalog
2001ACFSLE57 XL, 31448
Primary DI / UDI-DI
00640095314486
FDA product code
IOY
GMDN term
Compression/pressure glove
Device class
Class I
Regulation number
890.3475
GUDID distribution status
In Commercial Distribution

Related devices

Category: Compression/pressure glove

Other devices from Julius Zorn, Inc.

See all devices from Julius Zorn, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)