Setmark Inc.

GUDID 00854204008603

SETMARK INC.

General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair General-purpose stool/chair
Primary Device ID00854204008603
NIH Device Record Key92c42f8e-a0b9-48b6-ba96-493afe9fa78d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSetmark Inc.
Version Model NumberDC-108
Company DUNS080798558
Company NameSETMARK INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854204008603 [Primary]

FDA Product Code

FZMStool, Operating-Room

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-21

On-Brand Devices [Setmark Inc.]

00854204008597Cut - off Hydraulic stretcher, includes O2 tank & IV pole - Non Ferrous.NF-300
00854204008603DC-108

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