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Setmark Inc. SS-100H

by Setmark Inc.

Setmark Inc. SS-100H is a footstool (FDA Class I; FDA product code FZM, Stool, Operating-Room) made by Setmark Inc., listed in FDA GUDID since 28 Aug 2026 (UDI-DI 00854204008634), 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 Number00854204008634 UDI-DI Date28 Aug 2026ListedStatusListed 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  • Withdrawn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
Setmark Inc.
Generic name
Footstool
Model / reference
SS-100H
Primary DI / UDI-DI
00854204008634
FDA product code
FZM
GMDN term
Footstool
Device class
Class I
Regulation number
878.4950
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Similar devices

Other devices filed under FDA product code FZM (Stool, Operating-Room).

Other devices from Setmark Inc.

See all devices from Setmark Inc. →

Properties

  • Premarket exempt
  • Manufacturing date
Other properties (13, all answered No)